Final Regulatory Impact Analysis

0075 QSR FRIA 2024.pdf

Medical Devices; Quality System Regulation Amendments: FINAL RULE

Final Regulatory Impact Analysis

OMB: 0910-0073

Document [pdf]

Download: pdf | pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Medical Devices; Quality System Regulation Amendments
Docket No. FDA-2021-N-0507

Final Regulatory Impact Analysis
Final Regulatory Flexibility Analysis
Unfunded Mandates Reform Act Analysis

Economics Staff
Office of Economics and Analysis
Office of Policy, Legislation, and International Affairs
Office of the Commissioner

2022-635

Table of Contents
I. Introduction and Summary
A. Introduction
B. Summary of Costs and Benefits
C. Comments on the Preliminary Economic Analysis of Impacts and Our Responses
D. Summary of Changes
II. Final Regulatory Impact Analysis
A. Background
B. Market Failure Requiring Federal Regulatory Action
C. Purpose of the Final Rule
D. Baseline Conditions
1. Comparison of the Current 21 CFR Part 820 and ISO 13485
2. Affected Establishments
3. Establishment Size
E. Cost Savings (Benefits) of the Final Rule
F. Costs of the Final Rule
G. Distributional Effects
H. International Effects
I. Uncertainty and Sensitivity Analysis
J. Analysis of Regulatory Alternatives to the Final Rule
III. Final Small Entity Analysis
IV. References

2022-635

I. Introduction and Summary
A. Introduction
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563,
Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866,13563, and 14094 direct us to assess all benefits, costs, and transfers of
available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 Section
3(f)(1) (as amended by Executive Order 14094) if they “have an annual effect on the economy of $200 million
or more (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs
(OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of
the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial,
or tribal governments or communities. OIRA has determined that this final rule is a significant regulatory action
under Executive Order 12866 section 3(f)(1)).
A rule is “major” under the Congressional Review Act/Small Business Regulatory Enforcement Fairness
Act if it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets
other criteria specified in the Congressional Review Act (5 U.S.C. 804(2)). OIRA has determined that this final
rule is a major rule under the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any
significant impact of a rule on small entities. Our small entities analysis (see Part III) indicates that the final rule
would result in net cost savings of over $500 million for medical device establishments deemed as small entities
by the Small Business Administration. Therefore, we certify that the final rule will not have a significant
economic impact on a substantial number of small entities.

2022-635

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement,
which includes an assessment of anticipated impacts, before issuing “any rule that includes any Federal mandate
that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private
sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after
adjustment for inflation is $177 million, using the most current (2022) Implicit Price Deflator for the Gross
Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this
amount.
B. Summary of Costs and Benefits and Transfers
Table 1 includes summary of estimated benefits (cost savings) and costs of the final rule. The benefit of
the final rule is estimated in terms of reduction of compliance effort, and consequently cost savings, for medical
device establishments that previously complied with both the QS regulation and ISO 13485. The costs of the
rule include initial training of personnel, and information technology and documentation updates for the
medical device industry and the FDA. There is also a one-time cost of reading and learning the rule for the
medical device establishments.
Table 1: Summary of Benefits, Costs and Distributional Effects of Final Rule (Millions $)
Primary
Estimate

Category

Benefits*

Annualized
Monetized
$M/year
Annualized
Quantified

Costs

Qualitative
Annualized
Monetized
$M/year
Annualized
Quantified

$540

Low
Estimate

$270

High
Estimate

Units
Year
Dollars

$1,349 2022

$561

$280

$1,401 2022

$8.20

$8.20 2022

$7.29

$7.29 2022

Discount Period
Rate
Covered
7%
3%
7%
3%
7%
3%
7%
3%

10 years
10 years

Notes
Benefits
are cost
savings
Benefits
are cost
savings

Qualitative
Federal
Annualized
Monetized
$M/year
From/ To
From:
Transfers
Other
Annualized
Monetized
$M/year
From/To
From:
State, Local or Tribal Government:
Small Business:
Effects
Wages:
Growth:

2022-635

7%
3%
To:

7%
3%

To:

* Estimated benefits are in terms of cost savings for medical device establishments that conform to the current Part 820 and ISO
13485. Other benefits that are not quantified potentially include quicker delivery and more efficient access to necessary devices for
patients, leading to improvement of quality of life for consumers.
Note: All figures are in millions of dollars.

We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the
final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 11) and at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

C. Comments on the Preliminary Economic Analysis of Impacts and Our Responses
On February 23, 2022, FDA published a proposed rule to amend Part 820 (87 Federal Register 10119).
In the paragraphs below, we describe and respond to the comments received on the Preliminary
Economic Analysis of Impacts (PRIA). The number assigned to each comment is purely for organizational
purposes and does not signify the comment’s value, importance, or the order in which it was received.
(Comment 1) A commenter inquired how will FDA “certify” that the proposed rule will not have a
significant economic impact on a substantial number of small entities. In addition, the commenter inquired
whether the “certification” refers to certification issued by medical device Notification Bodies.
(Response) The Regulatory Flexibility Act requires us to analyze regulatory options that would
minimize any significant impact of a rule on small entities. When it is determined that a proposed or final rule

2022-635

will not have a significant impact on a substantial number of small entities, FDA certifies the proposed or final
rule to that effect. In this FRIA, we assess that the final rule does not have an adverse impact on a substantial
number of small entities by showing that the final rule would result in a net annual cost savings of over $500
million for small businesses, as defined by the Small Business Administration (see Section III).
(Comment 2) A Commenter noted that ISO 13485 is a copyrighted document that may be associated
with a fee, and thus may not be accessible to all entities, and suggested that FDA make the standard
available and cost-free.
(Response) FDA agrees with the portion of the comment that notes that ISO 13485 is a copyrighted
document, but advises that a mechanism exists to enable any entity to access standards incorporated by
reference in the National Institute of Standards and Technology website, through its Standards Incorporated
By Reference portal at no cost. The website for the portal is located
here: https://www.nist.gov/standardsgov/accessing-standards-incorporatedreference#:~:text=The%20American%20National%20Standards%20Institute,of%20Federal%20Regulations
%20(CFR)
(Comment 3) A commenter stated that only initial training of FDA personnel is considered in the PRIA. In
addition, the commenter inquires on ongoing training of FDA personnel on other areas (e.g., combination
products, radiation-specific products).
(Response) Ongoing training of existing personnel and initial training of new personnel is a standard work
practice at the CDRH. CDRH personnel are trained in appropriate areas to be able to assess and support
regulatory effort of the medical device establishments. In this FRIA, we assess the costs of initial training of the
FDA on the final rule. Costs of future ongoing trainings (e.g., refreshers, technology updates) are offset or
accounted for by activities included in the baseline and are a continuation of our previous training practices.
(Comment 4) A commenter indicated that the annualized costs savings ($540M at 7% discount rate;
$561M at 3% discount rate) “would be negatable in the near term, and minor in the long term based on
standardization.”

2022-635

(Response) In the FRIA, we demonstrate that the final rule decreases the regulatory burden of certain
medical device establishments. However, it is expected that the regulatory burden of some medical device
establishments will remain unchanged as a result of the final rule; therefore, the cost savings would be negatable
in the near term or long term for these establishments. The cost-benefit analysis in the FRIA indicates that the
annual benefit ($540M at 7% discount rate) of the final rule significantly outweighs the annual cost ($8.20M at
7% discount rate).
D. Summary of Changes
We have made edits to the analysis based on changes applied to the final rulemaking. Specifically, we
updated data we previously used in the Preliminary Regulatory Impact Analysis of the proposed rule. The
updated data include:
-

Medical device establishments registered with the FDA. The number of establishments currently
registered with the FDA increased from 22,845 in the PRIA to 28,303. However, for this FRIA, we
excluded establishments registered as “initial importers” (3,009 establishments; see Table 2) as we
believe they would not be affected by the final rule. We believe that compliance effort by initial
importers would remain the same before and after the implementation of the final rule. The number of
domestic medical device establishments used in the FRIA increased to 10,269 (13,278 domestic
establishments – 3,009 initial importers) (PRIA: 8,631) while the number of foreign medical device
establishments increased to 15,025 (PRIA: 11,715) (see Table 2).

Size demographics of medical device establishments. We used the latest available (2021) U.S. Bureau of
Census County Business Pattern datasets to estimate the number of medical device establishments in
different size categories. Changes in size demographic of medical device establishments were not
significant.

Wage Rates. We used the latest available (May 2022) U.S. Bureau of Labor Statistics datasets to
determine labor costs and cost savings by the medical device industry as a result of the final rule. Across

2022-635

all labor categories, wages in the medical device industry increased, on average, by 10.05% between
2020 and 2022. We also used the 2022 GS pay scale to determine FDA labor costs.
-

Other Costs. We updated the costs for specialized software to assist very small medical device
establishments to conform to the final rule, and professional courses designed to train FDA personnel.
Pursuant to FDA’s response to public comments, the effective date of the final rule will be 2 years from

the publication of the final rule in the Federal Register. The scheduled effective date affects annualizations of
costs and cost savings. We estimate that the 2-year effective date decreases annual cost savings by
approximately $75M (from $590M to $515M) and decreases annual costs by approximately $1.1M (from
$8.9M to $7.8M) over a 10-year period (7% discount rate).
Overall, stakeholders did not raise concerns regarding the PRIA through the public comments that
would warrant structural changes to the analysis. Public comments are discussed above.
II. Final Regulatory Impact Analysis
A. Background
FDA has authority to promulgate regulations governing current Good Manufacturing Practices (CGMP)
under section 520(f) of the FD&C Act to ensure that the required methods are used in, and the facilities and
controls are used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices
intended for human use. The CGMP regulation is codified at 21 CFR part 820 (Part 820) and was previously
referred to as the Quality System (QS) regulation. In this final rule, FDA is amending Part 820 to harmonize
device CGMP requirements in Part 820 with the International Organization for Standardization (ISO)
requirements for medical devices under ISO 13485: 2016 (ISO 13485) by incorporating ISO 13485 by reference
in Part 820. The amended Part 820 is referred to as the Quality Management System Regulation (QMSR). ISO
13485 is used by regulatory authorities from other jurisdictions to govern quality management system

2022-635

requirements. FDA is also making conforming edits to 21 CFR Part 4 to clarify medical device requirements for
combination products, and to connect and align 21 CFR Part 4 with ISO 13485 and the final rule.
B. Market or Government Failure Requiring Federal Regulatory Action
Establishments in the medical device industry registered with the FDA must comply with the CGMP
requirements in Part 820. In addition, registered foreign establishments and domestic establishments that export
their medical devices comply with ISO 13485, which FDA considers to be substantially similar to the QS
regulation. The QS regulation and ISO 13485 were concurrently implemented in 1996. In 2016, the
International Organization for Standardization updated ISO 13485 in response to the latest quality management
practices, including changes in technology and regulatory requirements and expectations. Part 820 has not been
updated since a significant revision in 1996. The buildup of competing expectations for quality management
systems over time leads to duplicative and sometimes obsolete constraints which, in turn, results in increased
regulatory compliance cost to the industry potentially without concomitant added benefits to the consumers. As
a result, some firms are overburdened by redundant effort in complying with both the QS regulation and ISO
13485. The final rule amends Part 820 by incorporating by reference ISO 13485 requirements thereby
harmonizing Quality System expectations across regulatory jurisdictions and reducing the regulatory burden for
certain medical device manufacturers.
C. Purpose of the Final Rule
Many U.S. manufacturers have historically used two separate but similar requirements for quality
system management of their medical devices – the QS regulation and ISO 13485. While the QS regulation
requirements have been effective in ensuring that manufacturers of medical devices meet the applicable quality
system requirements for the U.S., harmonizing CGMP requirements with ISO 13485 will reduce the regulatory
burden on device manufacturers and align domestic and international requirements. U.S. device manufacturers
who distribute medical devices globally will have a harmonized quality management system to comply with
requirements of regulating agencies/bodies. In addition, incorporating ISO 13485 requirements into CGMP

2022-635

requirements for the U.S. has the potential to increase competitiveness of U.S. device manufacturers in a global
market.
D. Baseline Conditions and Overview of Final Regulatory Changes
1. Comparison of the QS regulation and ISO 13485
FDA considers the previous QS regulation and ISO 13485 to be the same or substantially similar, although
some provisions of the QS regulation did not correlate to a single specific requirement in ISO 13485. In some
instances, we found requirements needed better clarification, but we do not intend to take a position on the
matter of comparison; rather, these clarifications are intended to ensure that implementation of a QMS is
aligned with FDA expectations and regulations. In some instances, we determined that substituting a provision
from ISO 13485 instead of its counterpart in the QS regulation would reduce the amount of regulatory effort on
the regulated industry.
The requirements of the new QMSR are substantively similar to those of the previous QS regulation, but
organization of the QMSR differs from that of the QS regulation and it was not possible to assess the provisionby-provision increase or decrease of effort difference between the previous QS regulation and the new QMSR.
There is consensus that the final rule will decrease the regulatory burden of medical device establishments that
complied with both ISO 13485 and the previous QS regulation; some sources of costs savings for the industry
include reduction of effort in:
-

Preparation for inspections and audits. Given that the requirements of both ISO 13485 and the QMSR
will be aligned, FDA expects a reduction of industry effort to maintain a state of preparedness for
inspections and audits. With aligned requirements, the expectations for documentation to show
conformity to requirements should reduce the duplication of effort by industry in preparing for visits
from regulators.

Internal audits and management reviews. The final rule will result in establishments conducting internal
audits and management reviews based on aligned requirements as opposed to auditing and assessing
separately to comply with the requirements of the previous QS regulation and ISO 13485 individually.

2022-635

Training costs: The harmonization of requirements will reduce training costs of industry in that internal
training can now cover an aligned set of requirements. Maintaining multiple quality management
systems required training personnel on the requirements of both the QS regulation and ISO 13485 in
order to maintain a QMS that is in conformity with both.

Documentation requirements. While documentation requirements are substantively similar between the
previous QS regulation and ISO 13485, amending Part 820 through this final rule will lead to a
reduction of specific documentation types/files. The QS regulation contained requirements for certain
record types that are not specifically identified in ISO 13485, such as the quality system record, device
master record, design history file, and device history record. In the QMSR, FDA has removed
requirements for these record types, as we believe the elements that comprise these records are largely
required to be documented by other ISO 13485 clauses, with the result being a reduced burden on
establishments that no longer need to create separate files to maintain QS regulation-specific record
types.
In addition, the final rule clarifies some requirements compared to the previous QS regulation

and will lead to efficiency gains. For instance, in ISO 13485, there is a specific section requiring sterilization of
medical device products, including validation; whereas, the previous QS regulation required that processes
more generally be validated. The previous QS regulation specifically referenced sterilization as an example of a
type of process that must be validated in the preamble. The same is true of integrated risk management
requirements. The QS regulation explicitly addressed risk management activities only in the risk analysis
requirement within design validation in previous Part 820.30(g) whereas risk management requirements are
more specifically listed throughout clauses in ISO 13485. FDA’s expectation that establishments integrate risk
management activities across the total product lifecycle was discussed primarily within the preamble of the
rulemaking finalizing the QS regulation, which required entities to refer to the preamble to understand the
expectation as opposed to having it clearly listed with the requirements of documents.

2022-635

In lieu of estimating granular comparison of ISO 13485 and the QS regulation for establishments of
different sizes, we decide on an overall decrease of regulatory burden for the affected establishment. FDA
experts assess that the final rule would potentially result in, on average, between a 5% and 25% reduction of
compliance effort. In this analysis, we assume the effort of a medical device establishment that would have
complied with both the QS regulation and ISO 13485 would decrease by 10% by complying with the QMSR in
the final rule. We use different reduction of burden rates of 5% and 25% in the Sensitivity Analysis section to
measure the lower and upper bound estimates of these cost savings.
Affected Establishments
As of March 2023, there are 28,303 domestic and foreign medical device establishments registered with the
FDA (see Table 2). FDA believes that initial importers would not be affected by the final rule. Therefore, the
number of domestic establishments considered for the analysis is 10,269 (13,278 – 3,009).

Table 2. Medical Device Establishments Registered with the FDA, 2023
Establishment Type
Domestic Foreign Total
Manufacturer/Complaint File Handler
6,320 11,376 17,696
Contract Manufacturer
1,158
1,732 2,890
Contract Sterilizer
68
166
234
Specification Developer
1,537
514 2,051
Re-processor of Single Use Devices
26
4
30
U.S. Manufacturer of Export Only Devices
120
0
120
Re-packager/Re-labeler
1,020
191 1,211
Remanufacturer
15
8
23
Foreign Exporter/Private Label Distributor
1,024 1,024
Initial Importer
3,009
3,009
Unknown
5
10
15
Total
13,278 15,025 28,303
*FDA, CDRH, March 2023.

2. Establishment Size
To determine the size demographics of medical device manufacturers, we use information from United
States Census Bureau’s 2020 County Business Patterns (CBP) for the North American Industry Classification
System (NAICS) codes typically used to identify medical device manufacturers (Table 3).

Table 3. NAICS Codes for Medical Device Manufacturers
NAICS
Code
Establishment description
325413 In-vitro diagnostic substance manufacturing
334510 Electromedical and electrotherapeutic apparatus manufacturing
334517 Irradiation apparatus manufacturing
339112 Surgical and medical instrument manufacturing
339113 Surgical appliance and supplies manufacturing
339114 Dental equipment and supplies manufacturing
339115 Ophthalmic goods manufacturing
Total Establishments

2022-635

Number of
Establishments
254
919
134
1,291
1,854
544
461
5,457

Source: United States Census Bureau, 2020 County Business Patterns, Link: https://data.census.gov, Accessed: March 2023.

We distribute medical device establishments into five size categories: very small (1-9 employees), small
(10-19 employees), medium (20-99 employees), large (100-249 employees), and very large (250+ employees).
The 2020 CBP data for NAICS codes described in Table 3 indicates that approximately 52.12% of all
manufacturing establishments are considered very small (1-9 employees), 12.35% are small establishments (1019 employees), 21.39% are medium-sized establishments (20-99 employees), 7.75% are large (100-249
employees), and 6.40% are very large (250+ employees) (see Tables 4 and 7). We use these proportions to
estimate numbers of manufacturers of medical devices registered with FDA by employment size. The CBP data
indicates that the very small establishments are defined as establishments that have a payroll of under $0.5
million.
Because we do not have robust data on the number of firms that currently comply with ISO 13485, we
are using very small domestic medical device manufacturing establishments to represent those who will
proportionally bear a greater burden of one-time costs by the final rule. As such, for the sake of this analysis we
assume that very small medical device manufacturing establishments currently do not sell their products abroad
and do not comply with ISO 13485.
Table 4. Size of Medical Device Manufacturing Establishments by Number of Employees for Selected
NAICS Codes
Establishment Size (no. of employees)
NAICS
Very Small
Small
Medium
Large
Very large
Code
(1-9)
(10-19)
(20-99)
(100-249)
(250+)
Total
88
33
72
23
38
254
325413

334510
334517
339112
339113
339114
339115
Total
Proportion

434
50
581
1,083
381
227
2,844
52.12%

92
20
155
229
63
82
674
12.35%

230
38
289
366
68
104
1,167
21.39%

2022-635

73
14
156
101
21
35
423
7.75%

90
919
12
134
110
1,291
75
1,854
11
544
13
461
349
5,457
6.40% 100.00%

Source: United States Census Bureau, 2020 County Business Patterns, https://data.census.gov, March 2023.

We also assume that very small foreign medical establishments do not export their products to the US.
In addition, we assume that all foreign medical device establishments that currently export to the U.S. comply
with ISO 13485. To determine the proportions of small, medium, large, and very large foreign registered
establishments, we extrapolate the proportions in Table 5 for those size categories. For example, the proportion
of small foreign medical device establishments to all foreign establishments is 25.79% (12.35% ÷ (12.35% +
21.39% + 7.75% + 6.40%)). Similarly, the proportion of foreign companies that are medium, large, and very
large are 44.66%, 16.19%, and 13.36% respectively (see Table 7).
To determine the size demographics of importers of medical device products, we use information from
CBP for the NAICS codes typically used to identify medical device importers (Table 5).
Table 5. NAICS Codes for Medical Device Importers
NAICS Code Establishment description
Medical, dental, and hospital equipment and supplies
423450
merchant wholesalers
423460
Ophthalmic goods merchant wholesalers
Total Establishments

No. of Ests.
10,761
1,020
11,781

Source: United States Census Bureau, 2020 County Business Patterns, Link: https://data.census.gov, Accessed: March 2023.

The 2020 CBP data for NAICS codes described in Table 3 indicates that approximately 73.25% of all
medical device importers are considered very small (1-9 employees), 9.77% are small-sized establishments,
12.57% are medium sized establishments (20-99 employees), 2.76% are large (100-249 employees), and 1.66%
are very large (250+ employees) (see Tables 6 and 7).
Table 6. Size of Medical Device Importers by Number of Employees for Selected NAICS Codes
Establishment Size (no. of employees)
NAICS Code

423450
423460
Total
Proportion

Very Small
(1-9)
7,936
693
8,629
73.25%

Small
Medium
(10-19)
(20-99)
1,035
1,313
116
168
1,151
1,481
9.77% 12.57%

2022-635

Large
(100-249)
291
34
325
2.76%

Very large
Total
(250+)
186
10,761
9
1020
195
11,781
1.66% 100.00%

Source: United States Census Bureau, 2020 County Business Patterns, Link: https://data.census.gov, Accessed: March 2023.

Table 7. Proportion of Medical Device Establishments by Type and Establishment Size
Establishment Size (no. of employees)
Establishment
Very Small
Small
Medium
Large
Very Large
Type
(1-9)
(10-19)
(20-99)
(100-249)
(250+)
Domestic
52.12%
12.35%
21.39%
7.75%
6.40%
manufacturers
Foreign
25.79%
44.66%
16.19%
13.36%
manufacturers
N/A*
Importers
73.25%
9.77%
12.57%
2.76%
1.66%
*

We assume that very small foreign medical device establishments do not export their products to the US.

We use the number of medical device establishments registered with FDA (Table 2) and the proportion of
medical device establishment by type and size (Table 7) to estimate the distribution of medical device
establishments by type and employee size (see Tables 8a and 8b). The final rule increases the burden of very
small domestic medical device manufacturers to switch their compliance from the previous QS regulation to the
QMSR, while it decreases the burden of all other medical device establishments by moving from compliance
with both the QS regulation and ISO 13485 to the QMSR. Table 8a shows that there are 5,352 very small
domestic medical device establishments, which are establishments that we assume have not previously
complied with ISO 13485 in addition to the previous QS regulation. These establishments incur a net cost as a
result of the final rule. Other medical device establishments, 19,942 (4,917 domestic and 15,025 foreign
establishments), experience net cost savings due to the final rule (see Tables 8a and 8b). The total number of
medical device establishments that will be covered under the final rule is 25,294 (10,269 domestic
establishments + 15,025 foreign establishments) (see Tables 8a and 8b).
Table 8a. Universe of Domestic Medical Device Establishments Affected by the Final Rule
Establishment Type
Domestic
Domestic

Manufacturer/Complaint File
Handler
Contract Manufacturer
Contract Sterilizer
Specification Developer
Re-processor of Single Use
Devices
U.S. Manufacturer of Export
Only Devices
Re-packager/Re-labeler
Remanufacturer
Foreign Exporter/Private Label
Distributor
Unknown
Total Manufacturers
Initial Importers
TOTAL
Very Small Manufacturers
All Other Manufacturers

Very
Small
(1-9)

2022-635

Small
(10-19)

Medium
(20-99)

Large
(100-249)

Very Large
(250+)

3,294
604
35
801

781
143
8
190

1,352
248
15
329

490
90
5
119

404
74
4
98

63
532
8

15
126
2

26
218
3

9
79
1

8
65
1

0
3
5,352
2,204
7,556
5,352

0
1
1,268
294
1,562

0
1
2,196
378
2,574

0
0
796
83
879

0
0
657
50
707

4,917

Note: We multiply number of establishments (Table 2) by appropriate size proportion (Table 7) to derive the above numbers.

Table 8b. Universe of Foreign Medical Device Establishments Affected by the Final Rule
Foreign
Establishment Type
Small
Medium
Large
Very Large
(10-19)
(20-99)
(100-249)
(250+)
Manufacturer/ Complaint File
Handler
2,934
5,081
1,842
1,519
Contract Manufacturer
447
774
280
231
Contract Sterilizer
43
74
27
22
Specification Developer
133
230
83
69
Re-processor of Single Use
Devices
1
2
1
1
U.S. Manufacturer of Export
Only Devices
0
0
0
0
Re-packager/Re-labeler
49
85
31
26
Remanufacturer
2
4
1
1
Foreign Exporter/Private Label
Distributor
264
457
166
137
Unknown
3
4
2
1
Total Manufacturers
3,876
6,710
2,432
2,007
Initial Importers
0
0
0
0
TOTAL
3,876
6,710
2,432
2,007
All Foreign Manufacturers
15,025

Note: We multiply number of establishments (Table 2) by appropriate size proportion (Table 7) to derive the above numbers.

2022-635

E. Cost Savings (Benefits) of the Final Rule
The primary benefit of the final rule is cost savings, which come from the reduction of demonstrating
compliance with both the previous QS regulation and ISO 13485. In Section D, we estimated the number of
small to very large medical device establishments that complied with both the QS regulation and ISO 13485;
these medical device establishments include 4,917 domestic manufacturing facilities (see Table 8a), and 15,025
foreign manufacturing facilities (see Table 8b). We assume the effort of a medical device establishment that
complied with both the previous QS regulation and ISO 13485 will decrease by 10% by complying with the
QMSR in this final rule. We use different reduction of burden rates of 5% and 25% in the Sensitivity Analysis
section to measure the lower and upper bound estimates of these benefits.
We use number of annual labor hours needed to comply with each provision of the previous QS regulation
based on information from the QS regulation final rule which was published in 1996 (21 CFR Parts 808, 812,
and 820, Vol. 61, No. 195, October 7, 1996, pgs. 52602-62). We include the assumption of 10% reduction in
burden to estimate annual labor hours saved for small to very large medical device establishments for
complying with the QMSR in this final rule compared to complying with both the previous QS regulation and
ISO 13485 for each provision of the previous QS regulation. We then use information from the QS regulation
1996 final rule to determine the proportion of types of labor needed to comply with each provision of that
regulation, and wage rates published by U.S. Bureau of Labor Statistics (BLS) (see Table 9) to estimate cost
savings (reduction in burden) of complying with this QMSR final rule for certain establishments. Wage rates
have been doubled to include overhead.
These annual cost savings are estimated by each subpart of the previous QS regulation, below. Table 10
presents summary annual cost savings for small to very large medical device establishments to comply with the
QMSR in this final rule.
Table 9. Medical Device Industry Wage Rates for Selected Labor Categories – NAICS 339100
Wages (/hour)
Category
Labor Category
2022*
Code
Vice president
$118.48
11-1011
Upper management
$73.23
11-2000

Middle management
Technical
Admin support
Clerical

$71.25
$43.68
$34.16
$19.02

2022-635

11-3000
Multiple
43-6011
43-4070

*Source: May 2022 National Occupational Employment and Wage Estimates. U.S. Bureau of Labor Statistics.
Link: https://www.bls.gov/oes/current/oes_nat.htm#11-0000, Last accessed: November 2023.
Note: All wage rates are doubled in calculation of costs and cost savings to account for overhead costs.

Table 10. Annual Cost Savings for Small to Very Large Medical Device Manufacturing Establishments
Previous Part 820 Subpart
Cost Savings
Subpart A – General Provisions*
N/A
Subpart B – Quality System Requirements (see Table 14)
$8,682,559
Subpart C – Design Controls (see Table 18)
$538,590,471
Subpart D – Document Controls (see Table 21)
$643,502
Subpart E – Purchasing Controls (see Table 25)
$22,853,554
Subpart F – Identification and Traceability (see Table 28)
$233,989
Subpart G – Production and Process Controls (see Table 32)
$2,379,851
Subpart H – Acceptance Activities (see Table 35)
$343,194
Subpart I – Nonconforming Product (see Table 38)
$643,502
Subpart J – Corrective and Preventive Action (see Table 41)
$643,502
Subpart K – Labeling and Packaging Control*
$343,194
Subpart L – Handling, Storage, Distribution, and Installation (see Table 44)
$686,388
Subpart M – Records (see Table 47)
$643,502
Subpart N – Servicing (see Table 50)
$643,502
Subpart O – Statistical Techniques (see Table 53)
N/A
Total Annual Cost Savings
$577,330,707
Note: These are undiscounted annual cost savings.

Subpart A – General Provisions
Subpart A of the previous QS regulation describes the scope, legal authority, and definitions of terms used
in the previous QS regulation. It also states that manufacturers must establish and maintain a quality system. In
this final rule for the QMSR, FDA is not modifying the scope of manufacturers and products subject to Part
820. Because there are differences between definitions for terms in the previous QS regulation and in Clause 3
of ISO 13485 and its normative reference, ISO 9000, FDA is modifying Part 820.3 to retain, revise, and
withdraw certain definitions previously found in the QS regulation. The one-time cost of understanding how
the final rule modifies the definitions in Part 820.3 are discussed in Section VIII.F, below. The annual cost
savings associated with maintaining a quality system is estimated in Subpart B, below.
Subpart B – Quality System Requirements

2022-635

Subpart B of the previous QS regulation pertained to management’s responsibility for assuring the existence
and implementation of a quality system by documentation, and communication to employees of their quality
policy and objectives. This final rule replaces the previous requirements with substantially similar requirements
in ISO 13845. We assume that each medical device establishment that complied with both the previous QS
regulation and ISO 13485 will require 10% fewer annual labor hours to comply with the provisions of the final
rule that correspond to provision(s) found in Subpart B of the previous QS regulation, as explained in Section
D.1. of this document. In the sensitivity analysis section, we compare the decrease in compliance effort by 5%
and 25%. Table 11 shows the number of annual labor hours saved for a medical device establishment
complying with the QMSR in this final rule organized by each provision of Subpart B of the previous QS
regulation.
Table 11. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart B of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart B (Part 820.20
- 820.25)
Small
Medium
Large
Very Large
Previous 820.20(a) Quality Policy
- Maintain Quality Policy1
1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8
Labor hours saved
0.1
0.1
0.2
0.2
Previous 820.20(b) Organization
- Maintain organizational structure
0
1
2
2
Comply with Final Rule2
0
0.9
1.8
1.8
Labor hours saved
0
0.1
0.2
0.2
Previous 820.20(c) Management Review
8
- Review by management representative1
12
16
24
2
Comply with Final Rule
7.2
10.8
14.4
21.6
Labor hours saved
0.8
1.2
1.6
2.4
Previous 820.20(d) Quality Planning
- Maintain quality plan1
4
6
8
10
Comply with Final Rule2
3.6
5.4
7.2
9
Labor hours saved
0.4
0.6
0.8
1
Previous 820.20(e) Quality System
Procedures
4
- Maintain QSP1
6
8
10
2
Comply with Final Rule
3.6
5.4
7.2
9
Labor hours saved
0.4
0.6
0.8
1
Previous 820.22 Quality Audit
1
- Maintain procedures1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8

Labor hours saved
Previous 820.25 Personnel
- Maintain procedures1
Comply with Final Rule2
Labor hours saved

2022-635

0.1

0.2

1
0.9
0.1

2
1.8
0.2

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to complying with the QMSR
in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart B of the previous QS regulation
(see Table 12), and appropriate wage rates and overhead costs (see Table 9) to estimate benefits of complying
with the QMSR in this final rule for affected establishments.
Table 12. Proportion of Annual Labor by Labor Category, Subpart B of Previous QS Regulation
Labor Category
QS Regulation, Subpart B
Vice
Upper
Middle
Admin
Technical
Clerical
(820.20 - 820.25)
Previous 820.20(a) Quality
Policy
- Maintain Quality Policy
Previous 820.20(b)
Organization
- Maintain organizational
structure
Previous 820.20(c) Management
Review
- Review by management
representative
Previous 820.20(d) Quality
Planning
- Maintain quality plan
Previous 820.20(e) Quality
System Procedures
- Maintain QSP
Previous 820.22 Quality Audit
- Maintain procedures
Previous 820.25 Personnel
- Maintain procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

Support

50%

80%

10%

100%

20%

70%

10%

20%

70%

10%

20%

70%

10%

20%

70%

10%

Using the number of hours saved in annual labor (Table 11) by proportion of labor category (Table 12),
and by appropriate wage rate and overhead costs (Table 9), we determine the benefit of reduced annual labor

2022-635

burden to comply with provisions of the QMSR corresponding to Subpart B of the previous QS regulation for
affected entities (see Tables 13a and 13b). Benefits of complying with the QMSR will result in a cost savings of
approximately $8.7 million per year for the affected entities by moving from compliance with both ISO 13485
and the previous QS regulation to the final rule (see Table 14).
To illustrate estimated figures in Table 13a, as an example we use estimated cost savings of $18,001 for
small domestic medical device establishments to comply with the section of the QMSR that corresponds to
Section 820.20(a) of the previous QS regulation. We expect that a small medical device establishment saves 0.1
hours as a result of the final rule (see Table 11). We use proportions of labor type to comply with the section of
the QMSR that corresponds to section 820.20(a) of the previous QS regulation; namely, 50% for Vice President
and 50% for Upper Management (see Tale 12) by their appropriate fully-loaded wage rates (hourly wage rates +
benefits equaling 100% of wages). Fully-loaded wage rate for Vice President is calculated as $236.96 ($118.48/
hour (see Table 9) x 2), and $146.46/hour ($73.23/hour (see Table 9) x 2) for Upper Management.
Therefore, on average, a small medical device establishment would save approximately $17 when
complying with the QMSR in this final rule: [0.1 hour x ($236.96/hour x 50%)] + [0.1 hour x ($146.46/hour x
50%)] = $19.17; rounded to $19 for presentation in Table 13a. We multiply the unit cost savings of $19.17by
number of small domestic medical device establishments (1,268.34; rounded to 1,268 for presentation in Table
13a) to obtain estimated cost savings of all small domestic medical device establishments: $19.17/establishment
x 1,268.34 establishments = $24,315.26; rounded to $24,315for presentation in Table 13a. The same process is
repeated throughout the document.
Table 13a. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart B of the QS Regulation
Establishment Size
QS Regulation, Subpart
Total
B (820.20 - 820.25)
Small
Medium
Large
Very large
No. of Establishments
1,268
2,196
796
657
4,917
Previous 820.20(a)
Quality Policy
Unit cost saving
$19
$19
$38
$38
Cost Savings
$24,315
$42,101
$30,520
$25,181
$122,117
Previous 820.20(b)
Organization
Unit cost saving
$0
$14
$27
$27

Cost Savings
Previous 820.20(c)
Management Review
Unit cost saving
Cost Savings
Previous 820.20(d)
Quality Planning
Unit cost saving
Cost Savings
Previous 820.20(e)
Quality System
Procedures
Unit cost saving
Cost Savings
Previous 820.22 Quality
Audit
Unit cost saving
Cost Savings
Previous 820.25
Personnel
Unit cost saving
Cost Savings
Total Cost Savings

2022-635

$29,696

$21,527

$17,761

$68,984

$117
$148,608

$176
$385,963

$234
$186,532

$352
$230,850

$951,953

$53
$67,397

$80
$175,043

$106
$84,597

$133
$87,247

$414,283

$53
$67,397

$80
$175,043

$106
$84,597

$133
$87,247

$414,283

$13
$16,849

$13
$29,174

$27
$21,149

$27
$17,449

$84,622

$13
$16,849
$341,417

$13
$29,174
$866,193

$27
$21,149
$450,071

$27
$17,449
$84,622
$483,184 $2,140,865

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Table 13b. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart B of the QS Regulation, Foreign Establishments
Establishment Size
QS Regulation, Subpart
Total
B (820.20 - 820.25)
Small
Medium
Large
Very large
No. of Establishments
3,876
6,710
2,432
2,007
15,025
Previous 820.20(a)
Quality Policy
Unit cost saving
$19
$19
$38
$38
Cost Savings
$74,298
$128,644
$93,259
$76,944
$373,146
Previous 820.20(b)
Organization
Unit cost saving
$0
$14
$27
$27
Cost Savings
$0
$90,739
$65,780
$54,272
$210,791
Previous 820.20(c)
Management Review
Unit cost saving
$117
$176
$234
$352
Cost Savings
$454,092 $1,179,359
$569,973
$705,392
$2,908,817
Previous 820.20(d)
Quality Planning
Unit cost saving
$53
$80
$106
$133
Cost Savings
$205,941
$534,867
$258,496
$266,593
$1,265,897
Previous 820.20(e)
Quality System
Procedures

Unit cost saving
Cost Savings
Previous 820.22 Quality
Audit
Unit cost saving
Cost Savings
Previous 820.25
Personnel
Unit cost saving
Cost Savings
Total Cost Savings

2022-635

$53
$205,941

$80
$534,867

$106
$258,496

$133
$266,593

$1,265,897

$13
$51,485

$13
$89,144

$27
$64,624

$27
$53,319

$258,572

$13
$51,485
$1,043,244

$13
$89,144
$2,646,765

$27
$64,624
$1,375,252

$27
$53,319
$1,476,432

$258,572
$6,541,693

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Table 14. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart B of the QS Regulation
QS Regulation, Subpart B (820.20 - 820.25)
Cost Savings
Previous 820.20(a) Quality Policy
$495,263
Previous 820.20(b) Organization
$279,775
Previous 820.20(c) Management Review
$3,860,770
Previous 820.20(d) Quality Planning
$1,680,181
Previous 820.20(e) Quality System Procedures
$1,680,181
Previous 820.22 Quality Audit
$343,194
Previous 820.25 Personnel
$343,194
Total Annual Cost Savings, Subpart B
$8,682,559
Note: These costs are the sum of costs in Tables 13a and 13b.

Subpart C – Design Controls
Subpart C of the previous QS regulation required each manufacturer to establish a formal, documented
program for assuring that design requirements were properly established, verified, and translated into design
specifications. This final rule replaces the previous requirements with substantially similar requirements in ISO
13845. The system employed by medical device establishments was required to address issues of design and
development planning, design input, design review, design verification, design output, design transfer, and
design changes. We assume that each medical device establishment that complied with both the previous QS
regulation and ISO 13485 will require 10% fewer annual labor hours to comply with the provisions of the final
rule that correspond to provisions found in Subpart C of the previous QS regulation, as explained in Section
D.1. of this document. In the sensitivity analysis section, we compare the decrease in compliance effort by 5%
and 25%. Table 15 shows the number of annual labor hours saved for a medical device establishment
complying with the final rule, organized by each provision of Subpart C of the previous QS regulation.

2022-635

Table 15. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart C of the Previous QS Regulation
QS Regulation, Subpart C
Establishment Size
(Part 820.30)
Small
Medium
Large
Very large
Previous 820.30(a) Design
Controls, General
- Maintain procedure1
3.0
6.0
15.0
56.0
2
Comply with Final Rule
2.7
5.4
13.5
50.4
Labor hours saved
0.3
0.6
1.5
5.6
Previous 820.30(b) Design
and Development Planning
- Maintain standardized plan1
820.30(a)
820.30(a)
820.30(a)
820.30(a)
- Update and approve plan as
design evolves1
32.0
104.0
208.0
520.0
2
Comply with Final Rule
28.8
93.6
187.2
468.0
Labor hours saved
3.2
10.4
20.8
52.0
Previous 820.30(c) Design
Input
- Maintain procedure
requirements1
820.30(a)
820.30(a)
820.30(a)
820.30(a)
Previous 820.30(d) Design
Output
- Maintain procedures1
820.30(a)
820.30(a)
820.30(a)
820.30(a)
Previous 820.30(e) Design
Review
- Maintain procedures1
820.30(a)
820.30(a)
820.30(a)
820.30(a)
- Conduct periodic design
review meeting1
77.0
312.0
749.0
2,496.0
2
Comply with Final Rule
69.3
280.8
674.1
2,246.4
Labor hours saved
7.7
31.2
74.9
249.6
- Record minutes of design
review meeting1
5.0
16.0
31.0
78.0
2
Comply with Final Rule
4.5
14.4
27.9
70.2
Labor hours saved
0.5
1.6
3.1
7.8
Previous 820.30(f) Design
Verification
- Maintain procedures1
820.30(a)
820.30(a)
820.30(a)
820.30(a)
- Conduct periodic design
249.0
809.0
1,619.0
4,047.0
review meeting1
2
Comply with Final Rule
224.1
728.1
1,457.1
3,642.3
Labor hours saved
24.9
80.9
161.9
404.7
Previous 820.30(g) Design
Validation
- Maintain procedures1
820.30(a)
820.30(a)
820.30(a)
820.30(a)
- Test under actual or
simulated use conditions1
820.30(f)
820.30(f)
820.30(f)
820.30(f)
- Document validation in
DHF1
820.30(f)
820.30(f)
820.30(f)
820.30(f)

Previous 820.30(h) Design
Transfer
- Maintain procedures1
- Review design before
release1
Comply with Final Rule2
Labor hours saved
Previous 820.30(i) Design
Changes
- Maintain written procedures1
- Review and approve design
changes1
Comply with Final Rule2
Labor hours saved
Previous 820.30(j) Design
History File
- Maintain procedures1
- Compile design history
record1
Comply with Final Rule2
Labor hours saved

820.30(a)

6.0
5.4
0.6
820.30(a)

820.30(a)

21.0
18.9
2.1
820.30(a)

56.0
50.4
5.6
820.30(a)

2022-635

42.0
37.8
4.2

3.0
2.7
0.3

104.0
93.6
10.4

820.30(a)

182.0
163.8
18.2
820.30(a)

820.30(a)

364.0
327.6
36.4

910.0
819.0
91.0

820.30(a)

10.0
9.0
1.0

820.30(a)

21.0
18.9
2.1

52.0
46.8
5.2

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to the QMSR in this final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportion of types of labor needed to comply with each section of Subpart C of the previous QS regulation (see
Table 16), and appropriate wage rates and overhead costs (see Table 9) to estimate the burden reduction of
complying with the QMSR in this final rule for affected establishments.
Table 16. Proportion of Annual Labor by Labor Category, Subpart C of the Previous QS Regulation
Labor Category
QS Regulation, Subpart C (Part
Vice
Upper
Middle
Admin
820.30)
President

820.30(a) Design Controls, General
- Maintain procedure
820.30(b) Design and Development Planning
- Maintain standardized plan
- Update and approve plan as design evolves
820.30(c) Design Input
- Maintain procedure requirements
820.30(d) Design Output
- Maintain procedures
820.30(e) Design Review
- Maintain procedures

Mgmt.

Technical

Support

Clerical

20%

70%

10%

820.30(a)
0%

820.30(a)
20%

820.30(a)
40%

820.30(a)
0%

820.30(a)

26
- Conduct periodic design review meeting
- Record minutes of design review meeting
820.30(f) Design Verification
- Maintain procedures
- Conduct periodic design review meeting
820.30(g) Design Validation
- Maintain procedures
- Test under actual or simulated use conditions
- Document validation in DHF
820.30(h) Design Transfer
- Maintain procedures
- Review design before release
820.30(i) Design Changes
- Maintain written procedures
- Review and approve design changes
820.30(j) Design History File
- Maintain procedures
- Compile design history record
Source: Part 820 Final Rule, 1996

2022-635

10%
0%

20%
0%

20%
50%

50%
0%

0%
0%

0%
50%

820.30(a)
0%

820.30(a)
40%

820.30(a)
60%

820.30(a)
0%

820.30(a)
820.30(f)
820.30(f)

820.30(a)
0%

820.30(a)
100%

820.30(a)
0%

820.30(a)
40%

820.30(a)
60%

820.30(a)
0%

820.30(a)
100%

820.30(a)
0%

Using the number of hours saved in annual labor (Table 15) by proportion of labor category (Table 16),
and by appropriate wage rate and overhead costs (Table 9), we determine the cost savings from reduced annual
labor burden to comply with provisions of the QMSR corresponding to Subpart C of the previous QS regulation
for affected establishments (see Tables 17a and 17b). Benefits of complying with the QMSR will result in cost
savings of approximately $539 million per year for the affected entities by moving from compliance with both
ISO 13485 and the previous QS regulation to the final rule (see Table 18).
Table 17a. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart C of the QS Regulation, Certain Domestic Establishments
QS Regulation, Subpart
Totals
C (Part 820.30)
Establishment Size
Small
Medium
Large
Very Large
1,268
2,196
796
657
4,917
No. of Establishments
820.30(a) Design Controls,
General
- Maintain procedure
Unit cost saving
Cost Savings
820.30(b) Design and
Development Planning
- Maintain standardized plan
- Update and approve plan as
design evolves
Unit cost saving

$40
$50,548
820.30(a)
$388

$80
$175,043
820.30(a)
$1,261

$199
$158,619
820.30(a)
$2,522

$744
$488,581
820.30(a)
$6,304

$872,790

27
Cost Savings

$492,071

$2,768,993

2022-635

$2,007,342

$4,140,439

820.30(c) Design Input
- Maintain procedure
requirements

820.30(a)

820.30(d) Design Output
- Maintain procedures

820.30(a)

820.30(e) Design Review
- Maintain procedures
- Conduct periodic design
review meeting
Unit cost saving
Cost Savings
- Record minutes of design
review meeting
Unit cost saving
Cost Savings
820.30(f) Design Verification
- Maintain procedures
- Conduct periodic design
review meeting
Unit cost saving
Cost Savings
820.30(g) Design Validation
- Maintain procedures
- Test under actual or simulated
use conditions
- Document validation in DHF
820.30(h) Design Transfer
- Maintain procedures
- Review design before release
Unit cost saving
Cost Savings
820.30(i) Design Changes
- Maintain written procedures
- Review and approve design
changes
Unit cost saving
Cost Savings
820.30(j) Design History File
- Maintain procedures
- Compile design history record
Unit cost saving
Cost Savings

$9,408,845

$964
$1,222,454

$3,905
$8,576,445

$9,375
$7,462,839

$31,243
$20,518,796

$37,780,533

$45
$57,246

$144
$317,182

$280
$222,751

$704
$462,421

$1,059,600

820.30(a)

$2,725
$3,455,684

$8,852
$19,439,904

820.30(a)

820.30(f)
820.30(f)

820.30(a)

$85
$108,443
820.30(a)
$613
$777,182

$299
$657,172
820.30(a)
$1,991
$4,373,378

820.30(a)

$20
$25,996
$6,189,623

$68
$150,035
$36,458,152

820.30(a)
$17,715
$14,101,391

820.30(a)
$44,283
$29,082,609

$598
$476,408
820.30(a)
$3,983
$3,170,418
820.30(a)
$143
$114,204
$27,713,970

$1,482
$973,302

$66,079,587

$2,215,325

820.30(a)
$9,957
$6,539,455

$14,860,432

820.30(a)
$355
$233,319
$523,554
$62,438,923 $132,800,668

Total Cost Savings
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Table 17b. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart C of the QS Regulation, Foreign Establishments
Establishment Size

QS Regulation, Subpart
C (Part 820.30)
No. of Establishments
820.30(a) Design Controls,
General
- Maintain procedure
Unit cost saving
Cost Savings
820.30(b) Design and
Development Planning
- Maintain standardized plan
- Update and approve plan as
design evolves
Unit cost saving
Cost Savings
820.30(c) Design Input
- Maintain procedure
requirements
820.30(d) Design Output
- Maintain procedures
820.30(e) Design Review
- Maintain procedures
- Conduct periodic design
review meeting
Unit cost saving
Cost Savings
- Record minutes of design
review meeting
Unit cost saving
Cost Savings
820.30(f) Design Verification
- Maintain procedures
- Conduct periodic design
review meeting
Unit cost saving
Cost Savings
820.30(g) Design Validation
- Maintain procedures
- Test under actual or simulated
use conditions
- Document validation in DHF
820.30(h) Design Transfer
- Maintain procedures
- Review design before release
Unit cost saving
Cost Savings
820.30(i) Design Changes
- Maintain written procedures
- Review and approve design
changes
Unit cost saving
Cost Savings

2022-635

Small
3,876

Medium
6,710

Large
2,432

Very Large
2,007

$40
$154,456

$80
$534,867

$199
$484,680

$744
$1,492,922

820.30(a)
$388
$1,503,586

820.30(a)
$1,261
$8,461,020

820.30(a)
$2,522
$6,133,696

Totals
15,025

$2,666,925

820.30(a)
$6,304
$12,651,654

$28,749,956

820.30(a)

$964
$3,735,368

$3,905
$26,206,449

$9,375
$22,803,679

$31,243
$62,697,864 $115,443,360

$45
$174,924

$144
$969,191

$280
$680,645

820.30(a)

$704
$1,412,988

$3,237,748

820.30(a)

$8,852
$59,401,168

$17,715
$43,088,643

$44,283
$88,865,714 $201,914,818

820.30(a)

820.30(f)
820.30(f)

820.30(a)

$2,725
$10,559,293

$85
$331,361

$299
$2,008,076

820.30(a)

$613
$2,374,781

$1,991
$13,363,427

$598
$1,455,726
820.30(a)
$3,983
$9,687,626

$1,482
$2,974,053

$6,769,215

820.30(a)
$9,957
$19,982,160

$45,407,993

29
820.30(j) Design History File
820.30(a)
820.30(a)
820.30(a)
820.30(a)
- Maintain procedures
- Compile design history record
$20
$68
$143
$355
Unit cost saving
$79,434
$458,452
$348,966
$712,938
Cost Savings
$18,913,202
$111,402,649
$84,683,660
$190,790,292
Total Cost Savings
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

2022-635

$1,599,789
$405,789,803

Table 18. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart C of the QS Regulation
QS Regulation, Subpart C (Part 820.30)
Cost Savings
Previous 820.30(a) Design Controls, General
$3,539,715
Previous 820.30(b) Design and Development Planning
$38,158,801
Previous 820.30(c) Design Input
820.30(a)
Previous 820.30(d) Design Output
820.30(a)
Previous 820.30(e) Design Review
$157,521,241
Previous 820.30(f) Design Verification
$267,994,406
Previous 820.30(g) Design Validation
820.20(a), (f)
Previous 820.30(h) Design Transfer
$8,984,540
Previous 820.30(i) Design Changes
$60,268,425
Previous 820.30(j) Design History File
$2,123,343
Total Annual Cost Savings, Subpart C
$538,590,471
Note: These costs are the sum of costs in Tables 17a and 17b.

Subpart D – Document Controls
Subpart D of the current previous QS regulation required manufacturers to establish and maintain
procedures to control certain documents. The requirements included designation of individuals to manage
review, approval, distribution, and modifications of documents. This final rule replaces the previous
requirements with substantially similar requirements in ISO 13845. We assume that each medical device
establishment that complied with both the previous QS regulation and ISO 13485 will require 10% fewer annual
labor hours to comply with the provisions of the final rule that correspond to provisions found in Subpart D of
the previous QS regulation, as explained in Section D.1. of this document. In the sensitivity analysis section, we
compare the decrease in compliance effort by 5% and 25%. Table 19 shows the number of annual labor hours
saved for a medical device establishment complying with the QMSR in this final rule organized by each
provision of Subpart D of the previous QS regulation.
Table 19. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart D of the Previous QS Regulation
Establishment Size

QS Regulation, Subpart D (Part
820.40)
Previous 820.40 Document Controls
- Maintain written procedures1
Comply with Final Rule2
Labor hours saved

Small

2022-635

Medium Large
2
1.8
0.2

2
1.8
0.2

Very large

3
2.7
0.3

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar standards to the final rule.

4
3.6
0.4

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportion of types of labor needed to comply with each section of Subpart D of the previous QS regulation (see
Table 20), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings of complying
with the QMSR in this final rule for affected establishments.
Table 20. Proportion of Annual Labor by Labor Category, Subpart D of Previous QS Regulation
Labor Category
QS Regulation, Subpart D
Vice
Upper
Middle
Admin
(820.40)
820.40 Document Controls
- Maintain written procedures

President

Source: Part 820 Final Rule, 1996

Mgmt.

20%

Mgmt.

Technical

Support

Clerical

70%

10%

Using the number of hours saved in annual labor (Table 19) by proportion of labor category (Table 20), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with the provisions of the QMSR corresponding to Subpart D of the previous QS regulation for affected
entities (see Table 21). Benefits of complying with the QMSR will result in a cost savings of approximately
$644,000 per year for the affected entities by moving from compliance with both ISO 13485 and the previous
QS regulation to the final rule (see Table 21).
Table 21. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart D of the QS Regulation
QS Regulation,
Subpart D (Part
820.40)
No. of Establishments
820.40 Document
Controls

Small
1,268

Establishment Size, Domestic
Medium
Large
2,196
796

Totals
Very Large
657

4,917

- Maintain written
procedures
Unit cost saving
$27
Cost Savings
$33,699
Part 820 Provision
No. of Establishments
3,876
820.40 Document
Controls
- Maintain written
procedures
Unit cost saving
$27
Cost Savings
$102,971
Total Annual Cost Savings, Subpart D

2022-635

$27
$40
$58,348
$31,724
Establishment Size, Foreign
6,710
2,432

$27
$178,289

$40
$96,936

$53
$34,899

$158,669
Totals
15,025

2,007

$53
$106,637

$484,833
$643,502

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Subpart E – Purchasing Controls
Subpart E of the current previous QS regulation required each manufacturer to establish procedures to
assess suppliers, provide clear specification of component requirements, and conduct inspections and tests of a
supplier’s quality system. The manufacturer was required to also establish controls to assure that specifications
were properly described in procurement documents. This final rule replaces the previous requirements with
substantially similar requirements in ISO 13845. We assume that each medical device establishment that
complied with both the previous QS regulation and ISO 13485 will require 10% fewer annual labor hours to
comply with the provisions of the final rule that correspond to provisions found in Subpart E of the previous QS
regulation, as explained in Section D.1. of this document. In the sensitivity analysis section, we compare the
decrease in compliance effort by 5% and 25%. Table 22 shows the number of annual labor hours saved for a
medical device establishment complying with the QMSR in this final rule organized by each provision of
Subpart E of the previous QS regulation.
Table 22. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart E of the Previous QS Regulation
QS Regulation, Subpart E (Part 820.50)
Previous 820.50(a) Evaluation of Suppliers,
Contractors, and Consultants
- Review quality of suppliers1
Comply with Final Rule2
Labor hours saved
- Audit new suppliers1

Establishment Size
Medium
Large

Small
13
11.7
1.3
10

25
22.5
2.5
20

50
45
5
40

Very large
63
56.7
6.3
80

Comply with Final Rule2
Labor hours saved
Previous 820.50(b) Purchasing Data
- Review and approve purchasing documents1
Comply with Final Rule2
Labor hours saved

2022-635

9
1

18
2

36
4

72
8

5
4.5
0.5

39
35.1
3.9

129
116.1
12.9

60
54
6

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to the QMSR in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart E of the previous QS regulation
(see Table 23), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings of
complying with the QMSR in this final rule for affected establishments.
Table 23. Proportion of Annual Labor by Labor Category, Subpart E of Previous QS Regulation
Labor Category
QS Regulation, Subpart E (Part
Vice
Upper
Middle
Admin
820.50)
820.50(a) Evaluation of Suppliers,
Contractors, and Consultants
- Review quality of suppliers
- Audit new suppliers
820.50(b) Purchasing Data
- Review and approve purchasing
documents

President

Source: Part 820 Final Rule, 1996

Mgmt.

Technical

Support

Clerical

0%
0%

0%
100%

0%
0%

100%
0%

0%
0%

100%

Using the number of hours saved in annual labor (Table 22) by proportion of labor category (Table 23), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart E of the previous QS regulation for affected
establishments (see Tables 24a and 24b). Benefits of complying with the QMSR will result in cost savings of
approximately $23 million per year for the affected entities by moving from compliance with both ISO 13485
and the previous QS regulation to the final rule (see Table 25).
Table 24a. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart E of the QS Regulation, Certain Domestic Establishments
Part 820, Subpart E
No. of Establishments

Small
1,268

Establishment Size
Medium
Large
2,196
796

Very Large
657

Totals
4,917

820.50(a) Evaluation of
Suppliers, Contractors, and
Consultants
- Review quality of suppliers
Unit cost saving
Cost Savings
- Audit new suppliers
Unit cost saving
Cost Savings
820.50(b) Purchasing Data
- Review and approve
purchasing documents
Unit Cost Saving
Cost Savings
Total

2022-635

$173
$219,041

$332
$729,346

$664
$528,729

$837
$549,653

$2,026,769

$143
$180,738

$285
$625,878

$570
$453,722

$1,140
$748,694

$2,009,032

$34
$43,326

$266
$585,137

$881
$701,540

$410
$269,215

$1,599,217
$5,635,019

Table 24b. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart E of the QS Regulation, Foreign Establishments
Part 820, Subpart E
No. of Establishments
820.50(a) Evaluation of
Suppliers, Contractors, and
Consultants
- Review quality of suppliers
Unit cost saving
Cost Savings
- Audit new suppliers
Unit cost saving
Cost Savings
820.50(b) Purchasing Data
- Review and approve
purchasing documents
Unit Cost Saving
Cost Savings
Total

Small
3,876

Establishment Size
Medium
Large
6,710
2,432

Very Large
2,007

Totals
15,025

$173
$669,309

$332
$2,228,612

$664
$1,615,600

$837
$1,679,537

$6,193,058

$143
$552,268

$285
$1,912,453

$570
$1,386,406

$1,140
$2,287,733

$6,138,860

$34
$132,389

$266
$1,787,962

$881
$2,143,646

$410
$822,621

$4,886,618
$17,218,536

Table 25. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart E of the QS Regulation
Part 820, Subpart E Provision
Cost Savings
820.50(a) Evaluation of Suppliers, Contractors, and Consultants
$16,367,719
820.50(b) Purchasing Data
$6,485,836
Total Annual Cost Savings, Subpart E
$22,853,554
Note: These costs are the sum of costs in Tables 24a and 24b.

Subpart F – Identification and Traceability

2022-635

Subpart F of the previous QS regulation required manufacturers to establish and maintain procedures for
identifying their products during all stages of receipt, production, distribution, and installation to prevent mixups. In addition, manufacturers were also required to establish and maintain procedures for identifying with a
control number each unit, lot, or batch of finished critical medical devices or components. This final rule
replaces the previous requirements with substantially similar requirements in ISO 13845. We assume that each
medical device establishment that complied with both the previous QS regulation and ISO 13485 will require
10% fewer annual labor hours to comply with the provisions of the final rule that correspond to provisions
found in Subpart F of the previous QS regulation, as explained in Section D.1. of this document. In the
sensitivity analysis section, we compare the decrease in compliance effort by 5% and 25%. Table 26 shows the
number of annual labor hours saved for a medical device establishment complying with the QMSR in this final
rule organized by each provision of Subpart F of the previous QS regulation.
Table 26. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart F of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart F (Part
820.60)
Small
Medium Large
Very large
Previous 820.60 Identification
- Maintain written procedures1
1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8
Labor hours saved
0.1
0.1
0.2
0.2

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to the QMSR in this final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart F of the previous QS regulation
(see Table 27), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings of
complying with the final rule for affected establishments.
Table 27. Proportion of Annual Labor by Labor Category, Subpart F of Previous QS Regulation
Labor Category
QS Regulation, Subpart F (Part
Vice
Upper
Middle
Admin
820.60)
Previous 820.60 Identification
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

30%

Technical

Support

Clerical

70%

2022-635

Using the number of hours saved in annual labor (Table 26) by proportion of labor category (Table 27), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart F of the previous QS regulation for affected
entities (see Table 28). Benefits of complying with the QMSR will result in a cost saving of approximately
$234,000 per year for the affected entities by moving from compliance with both ISO 13485 and the previous
QS regulation to the final rule (see Table 28).
Table 28. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart F of the QS Regulation
QS Regulation,
Establishment Size, Domestic
Subpart F (Part
Totals
820.60)
Small
Medium
Large
Very Large
No. of
Establishments
1,268
2,196
796
657
4,917
820.60
Identification
- Maintain
written
procedures
Unit cost saving
$9
$9
$18
$18
Cost Savings
$11,488
$19,891
$14,419
$11,897
$57,695
Part 820
Establishment Size, Foreign
Totals
Subpart F
No. of
Establishments
3,876
6,710
2,432
2,007
15,025
820.60
Identification
- Maintain
written
procedures
Unit cost saving
$9
$9
$18
$18
Cost Savings
$35,103
$60,778
$44,060
$36,352
$176,294
Total Annual Cost Savings, Subpart F
$233,989
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Subpart G – Production and Process Controls
Subpart G of the previous QS regulation required manufacturers to establish and maintain procedures for
processing controls, environmental control, and cleaning and sanitation. It also required special processes to be
validated and monitored. This final rule replaces the previous requirements with substantially similar
requirements in ISO 13845. We assume that each medical device establishment that complied with both the

2022-635

previous QS regulation and ISO 13485 will require 10% fewer annual labor hours to comply with the provisions
of the final rule that correspond to provisions found in Subpart G of the previous QS regulation, as explained in
Section D.1. of this document. In the sensitivity analysis section, we compare the decrease in compliance effort
by 5% and 25%. Table 29 shows the number of annual labor hours saved for a medical device establishment
complying with the QMSR in this final rule, organized by each provision of Subpart G of the previous QS
regulation.
Table 29. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart G of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart G (Part 820.70 –
820.75)
Small
Medium
Large Very large
Previous 820.70(d) Personnel
- Maintain and use procedures1
2
2
3
7
2
Comply with Final Rule
1.8
1.8
2.7
6.3
Labor hours saved
0.2
0.2
0.3
0.7
Previous 820.70(i) Automated Processes
- Maintain written procedures1
2
2
3
4
2
Comply with Final Rule
1.8
1.8
2.7
3.6
Labor hours saved
0.2
0.2
0.3
0.4
Previous 820.72(a) Control of Inspection,
Measuring, and Test Equipment
- Maintain and use procedure1
1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8
Labor hours saved
0.1
0.1
0.2
0.2
Previous 820.75(b) Process Validation
- Maintain procedure1
2
2
3
4
2
Comply with Final Rule
1.8
1.8
2.7
3.6
Labor hours saved
0.2
0.2
0.3
0.4

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to complying with the QMSR
in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart G of the previous QS regulation
(see Table 30), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings from
complying with the QMSR in this final rule for affected establishments.
Table 30. Proportion of Annual Labor by Labor Category, Subpart G of Previous QS Regulation
Labor Category

QS Regulation, Subpart G (820.70
– 820.75)
820.70(d) Personnel
- Maintain and use procedures
820.70(i) Automated Processes
- Maintain written procedures
820.72(a) Control of Inspection,
Measuring, and Test Equipment
- Maintain and use procedure
820.75(b) Process Validation
- Maintain procedure

Source: Part 820 Final Rule, 1996

2022-635

Vice
Upper Middle
Admin
President Mgmt. Mgmt. Technical Support Clerical
0%

20%

70%

10%

20%

70%

10%

20%

70%

10%

20%

70%

10%

Using the number of hours saved in annual labor (Table 29) by proportion of labor category (Table 30), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart G of the previous QS regulation for affected
domestic and foreign entities (see Tables 31a and 31b). Benefits of complying with the QMSR will result in
cost savings of approximately $2.4 million per year for the affected entities by moving from compliance with
both ISO 13485 and the previous QS regulation to the final rule (see Table 32).
Table 31a. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart G of the QS Regulation, Certain Domestic Establishments
QS Regulation,
Establishment Size
Subpart G
Totals
(Part 820.70 –
820.75)
Small
Medium
Large
Very Large
No. of
Establishments
1,268
2,196
796
657
4,917
820.70(d)
Personnel
- Maintain and
use procedures
Unit cost saving
$27
$27
$40
$93
Cost Savings
$33,699
$58,348
$31,724
$61,073
$184,843
- Maintain
written
procedures
Unit cost saving
$27
$27
$40
$53
Cost Savings
$33,699
$58,348
$31,724
$34,899
$158,669
820.72(a)
Control of
Inspection,

Measuring, and
Test Equipment
- Maintain and
use procedure
Unit cost saving
Cost Savings
820.75(b)
Process
Validation
- Maintain
procedure
Unit cost saving
Cost Savings
Total Cost Savings

2022-635

$13
$16,849

$13
$29,174

$27
$21,149

$27
$17,449

$27
$33,699

$27
$58,348

$40
$31,724

$53
$34,899

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

$84,622

$158,669
$586,802

Table 31b. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart G of the QS Regulation, Foreign Establishments
QS
Establishment Size
Regulation,
Totals
Subpart B
(820.70 Small
Medium
Large
Very Large
820.75)
No. of
Establishment
s
3,876
6,710
2,432
2,007
15,025
820.70(d)
Personnel
- Maintain and
use procedures
Unit cost
saving
$27
$27
$40
$93
Cost Savings
$102,971
$178,289
$96,936
$186,615
$564,811
- Maintain
written
procedures
Unit cost
saving
$27
$27
$40
$53
$484,833
Cost Savings
$102,971
$178,289
$96,936
$106,637
820.72(a)
Control of
Inspection,
Measuring,
and Test
Equipment
- Maintain and
use procedure
Unit cost
saving
$13
$13
$27
$27

Cost Savings
820.75(b)
Process
Validation
- Maintain
procedure
Unit cost
saving
Cost Savings
Total Cost Savings

2022-635

$51,485

$89,144

$64,624

$53,319

$27
$102,971

$27
$178,289

$40
$96,936

$53
$106,637

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

$258,572

$484,833
$1,793,049

Table 32. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart G of the QS Regulation
Part 820 Provision
Cost Savings
820.70(d) Personnel
$1,393,155
820.72(a) Control of Inspection, Measuring, and Test Equipment
$343,194
820.75(b) Process Validation
$643,502
Total Annual Cost Savings, Subpart G
$2,379,851
Note: These costs are the sum of costs in Tables 31a and 31b.

Subpart H – Acceptance Activities
Subpart H of the previous QS regulation required manufacturers to establish and maintain procedures for
acceptance activities including inspections, tests, or other verification activities. This final rule replaces the
previous requirements with substantially similar requirements in ISO 13845. We assume that each medical
device establishment that complied with both the previous QS regulation and ISO 13485 will require 10% fewer
annual labor hours to comply with the provisions of the final rule that correspond to provisions found in Subpart
H of the previous QS regulation, as explained in Section D.1. of this document. In the sensitivity analysis
section, we compare the decrease in compliance effort by 5% and 25%. Table 33 shows the number of annual
labor hours saved for a medical device establishment complying with the QMSR in this final rule, organized by
each provision Subpart H of the previous QS regulation.
Table 33. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart H of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart H (Part
820.84)
Small
Medium Large
Very large
Previous820.84 Inspection, Measuring
and Testing Equipment
- Maintain written procedures1
1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8

Labor hours saved

2022-635

0.1

0.2

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to the QMSR in this final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportion of types of labor needed to comply with each section of Subpart H of the previous QS regulation (see
Table 34), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings of complying
with the QMSR in this final rule for affected establishments.
Table 34. Proportion of Annual Labor by Labor Category, Subpart H of the Previous QS Regulation
QS Regulation, Subpart H (Part
820.84)
Labor Category
820.84 Inspection, Measuring and
Testing Equipment
- Maintain written procedures

Source: Part 820 Final Rule, 1996

Vice
President

Upper
Mgmt.

20%

Middle
Mgmt.

70%

Technical

Admin
Support

Clerical

10%

Using the number of hours saved in annual labor (Table 33) by proportion of labor category (Table 34), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart H of the previous QS regulation for affected
establishments (see Table 35). Benefits of complying with the QMSR will result in cost savings of
approximately $344,000 per year for the affected entities by moving from compliance with both ISO 13485 and
the previous QS regulation to the final rule (see Table 35).
Table 35. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart H of the QS Regulation
QS Regulation,
Establishment Size, Domestic
Subpart H (Part
Totals
820.84)
Small
Medium
Large
Very Large
No. of Establishments
1,268
2,196
796
657
4,917
820.84 Inspection,
Measuring and
Testing Equipment
- Maintain written
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$16,849
$29,174
$21,149
$17,449
$84,622
Part 820 Subpart H
Establishment Size, Foreign
Totals
No. of Establishments
3,876
6,710
2,432
2,007
15,025

820.84 Inspection,
Measuring and
Testing Equipment
- Maintain written
procedures
Unit cost saving
$13
Cost Savings
$51,485
Total Annual Cost Savings, Subpart H

$13
$89,144

2022-635

$27
$64,624

$27
$53,319

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

$258,572
$343,194

Subpart I – Nonconforming Product
Subpart I of the previous QS regulation required manufacturers to establish and maintain written procedures
to control nonconforming products. The procedures were required to address the identification, documentation,
evaluation, segregation, and disposition of nonconforming products. This final rule replaces the previous
requirements with substantially similar requirements in ISO 13845. We assume that each medical device
establishment that complied with both the previous QS regulation and ISO 13485 will require 10% fewer annual
labor hours to comply with the provisions of the final rule that correspond to provisions found in Subpart I of
the previous QS regulation, as explained in Section D.1. of this document. In the sensitivity analysis section, we
compare the decrease in compliance effort by 5% and 25%. Table 36 shows the number of annual labor hours
saved for a medical device establishment complying with the QMSR in this final rule, organized by each
provision of Subpart I of the previous QS regulation.
Table 36. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart I of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart I (Part
820.90)
Small
Medium Large
Very large
Previous 820.90(a) Nonconforming
Product
- Maintain procedure1
2
2
3
4
2
Comply with Final Rule
1.8
1.8
2.7
3.6
Labor hours saved
0.2
0.2
0.3
0.4

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar standards to the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportion of types of labor needed to comply with each section of Subpart I of the previous QS regulation (see

2022-635

Table 37), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings to complying
with the QMSR in this final rule for affected establishments.
Table 37. Proportion of Annual Labor by Labor Category, Subpart I of Previous QS Regulation
Labor Category
QS Regulation, Subpart I
Vice
Upper Middle
Admin
Clerical
Technical
(Part 820.90)
820.90(a) Nonconforming
Product
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

20%

70%

Support

10%

Using the number of hours saved in annual labor (Table 36) by proportion of labor category (Table 37), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart I of the previous QS regulation for affected
entities (see Table 38). Benefits of complying with the QMSR will result in cost savings of approximately
$644,000 per year for the affected entities by moving from compliance with both ISO 13485 and the previous
QS regulation to the final rule (see Table 38).
Table 38. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart I of the QS Regulation
Establishment Size, Domestic
Part 820,
Totals
Subpart I
Small
Medium
Large
Very Large
No. of
Establishments
1,268
2,196
796
657
4,917
820.90(a)
Control of
Nonconformin
g Product
- Maintain
written
procedures
Unit cost
saving
$27
$27
$40
$53
Cost Savings
$33,699
$58,348
$31,724
$34,899
$158,669
Part 820,
Establishment Size, Foreign
Totals
Subpart I
No. of
Establishments
3,876
6,710
2,432
2,007
15,025
820.90(a)
Control of
Nonconformin
g Product

- Maintain
written
procedures
Unit cost
saving
$27
Cost Savings
$102,971
Total Annual Cost Savings, Subpart I

$27
$178,289

2022-635

$40
$96,936

$53
$106,637

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

$484,833
$643,502

Subpart J – Corrective and Preventive Action
Subpart J of the previous QS regulation required manufacturers to establish a program and maintain written
procedures to collect, correlate, and evaluate applicable internal and external quality control data for the
purpose of detecting and preventing quality-issue problems. Manufacturers were also required to use obtained
data from their program to determine possible solutions and document the corrective action selected and
implemented. This final rule replaces the previous requirements with substantially similar requirements in ISO
13845. We assume that each medical device establishment that complied with both the previous QS regulation
and ISO 13485 will require 10% fewer annual labor hours to comply with the provisions of the final rule that
correspond to provisions found in Subpart J of the previous QS regulation, as explained in Section D.1. of this
document. In the sensitivity analysis section, we compare the decrease in compliance effort by 5% and 25%.
Table 39 shows the number of annual labor hours saved for a medical device establishment complying with the
QMSR in this final rule, organized by each provision of Subpart J of the previous QS regulation.
Table 39. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart J of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart J (Part
820.100)
Small
Medium Large
Very large
Previous 820.100 Corrective and
Preventive Action
- Maintain written procedures1
2
2
3
4
Comply with Final Rule2
1.8
1.8
2.7
3.6
Labor hours saved
0.2
0.2
0.3
0.4

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to the QMSR in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart J of the previous QS regulation

2022-635

(see Table 40), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings from
complying with the QMSR in this final rule for affected establishments.
Table 40. Proportion of Annual Labor by Labor Category, Subpart J of Previous QS Regulation
Labor Category
QS Regulation, Subpart J
Vice
Upper
Middle
Admin
Technical
Clerical
(Part 820.100)
820.100 Corrective and
Preventive Action
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

20%

Support

Mgmt.

70%

10%

Using the number of hours saved in annual labor (Table 39) by proportion of labor category (Table 40), and
by appropriate wage rate and overhead costs (Table 9), we determine the cost savings of the reduced annual
labor burden to comply with provisions of the QMSR corresponding to Subpart J of the previous QS regulation
for affected entities (see Table 41). Benefits of complying with the QMSR will result in a cost savings of
approximately $644,000 per year for the affected entities by moving from compliance with both ISO 13485 and
the previous QS regulation to the final rule (see Table 41).
Table 41. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart J of the QS Regulation
QS Regulation, Subpart J (Part 820.100)
Establishment Size, Domestic
Totals
No. of Establishments
1,268
2,196
796
657
4,917
820.100 Corrective and Preventive Action
- Maintain written procedures
Unit cost saving
$27
$27
$40
$53
Cost Savings
$33,699
$58,348
$31,724
$34,899
$158,669
Part 820, Subpart J
Establishment Size, Foreign
Totals
No. of Establishments
3,876
6,710
2,432
2,007
15,025
820.100 Corrective and Preventive Action
- Maintain written procedures
Unit cost saving
$27
$27
$40
$53
Cost Savings
$102,971
$178,289
$96,936 $106,637
$484,833
Total Cost Savings, Subpart J
$643,502
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Subpart K – Labeling and Packaging Control
Subpart K of the previous QS regulation required medical device establishments to maintain a formal
system for the safe and proper handling and storage of medical device and manufacturing materials. Controls
that prevent mix-ups, deterioration, and other adverse effects on medical devices and manufacturing materials

2022-635

were also required to be established. This final rule replaces the previous requirements with substantially similar
requirements in ISO 13845. We assume that each medical device establishment that complied with both the
previous QS regulation and ISO 13485 will require 10% fewer annual labor hours to comply with the provisions
of the final rule that correspond to provisions found in Subpart K of the previous QS regulation, as explained in
Section D.1. of this document. In the sensitivity analysis section, we compare the decrease in compliance effort
by 5% and 25%. Table 42 shows the number of annual labor hours saved for a medical device establishment
complying with the QMSR in this final rule organized by each provision of Subpart K of the previous QS
regulation.
Table 42. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart K of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart K, (Part
820.120 – 820.130)
Small
Medium Large
Very large
820.120-820.122 Handling, Storage
- Maintain written procedures1
1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8
Labor hours saved
0.1
0.1
0.2
0.2

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to the QMSR in this final rule
.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart K of the previous QS regulation
(see Table 43), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings of
complying with the final rule for affected establishments.
Table 43. Proportion of Annual Labor by Labor Category, Subpart K of Previous QS Regulation
Labor Category
QS Regulation, Subpart K (Part
Vice
Upper
Middle
Admin
820.120 – 820.130)
820.120-820.122 Handling, Storage
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

20%

Mgmt.

70%

Technical

Support

Clerical

10%

Using the number of hours saved in annual labor (Table 42) by proportion of labor category (Table 43), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart K of the previous QS regulation for affected

2022-635

entities (see Table 44). Benefits of complying with the QMSR will result in cost savings of approximately
$344,000 per year for the affected entities by moving from compliance with both ISO 13485 and the previous
QS regulation to the final rule (see Table 44).
Table 44. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart K of the QS Regulation
QS Regulation, Subpart
Establishment Size, Domestic
K (Part 820.120 –
820.130))
Small
Medium
Large
Very Large
No. of Establishments
1,268
2,196
796
657
820.84 Inspection,
Measuring and Testing
Equipment
- Maintain written
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$16,849
$29,174
$21,149
$17,449
QS Regulation, Subpart
K (Part 820.120 –
820.130))
Establishment Size, Foreign
No. of Establishments
3,876
6,710
2,432
2,007
820.84 Inspection,
Measuring and Testing
Equipment
- Maintain written
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$51,485
$89,144
$64,624
$53,319
Total Annual Cost Savings, Subpart K
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Subpart L – Handling, Storage, Distribution, and Installation
Subpart L of the previous QS regulation required manufacturers to establish and maintain written
procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to the medical
device product did not occur during handling, storage, distribution, or installation of the product. This final rule
replaces the previous requirements with substantially similar requirements in ISO 13845. We assume that each
medical device establishment that complied with both the previous QS regulation and ISO 13485 will require
10% fewer annual labor hours to comply with the provisions of the final rule that correspond to provisions
found in Subpart L of the previous QS regulation, as explained in Section D.1. of this document. In the
sensitivity analysis section, we compare the decrease in compliance effort by 5% and 25%. Table 45 shows the

Totals

$84

Totals
15

$258
$343

2022-635

number of annual labor hours saved for a medical device establishment complying with the QMSR in this final
rule, organized by each provision of Subpart L of the previous QS regulation.
Table 45. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart L of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart L (Part
820.140, 820.150)
Small
Medium Large
Very large
Previous820.140 Handling
- Maintain written procedures1
1
1
2
2
Comply with Final Rule 2
0.9
0.9
1.8
1.8
Labor hours saved
0.1
0.1
0.2
0.2
Previous 820.150 Storage(a)
- Maintain written procedures1
1
1
2
2
2
Comply with Final Rule
0.9
0.9
1.8
1.8
Labor hours saved
0.1
0.1
0.2
0.2

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to complying with the QMSR
in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart L of the previous QS regulation
(see Table 46), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings of
complying with the QMSR in this final rule for affected establishments.
Table 46. Proportion of Annual Labor by Labor Category, Subpart L of Previous QS Regulation
Labor Category
Part 820, Subpart L (Part
Vice
Upper
Middle
Admin
820.140, 820.150)
820.140 Handling
- Maintain written procedures
820.150 Storage(a)
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

20%

Mgmt.

Technical

Support

Clerical

70%

10%

70%

10%

Using the number of hours saved in annual labor (Table 45) by proportion of labor category (Table 46), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart L of the previous QS regulation (see Table 47).
Benefits of complying with the QMSR will result in a cost savings of approximately $687,000 per year for the
affected entities by moving from compliance with both ISO 13485 and the previous QS regulation to the final
rule (see Table 47).

2022-635

Table 47. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart L of the QS Regulation
Part 820, Subpart
Establishment Size, Domestic
L (Part 820.140,
Totals
820.150)
Small
Medium
Large
Very Large
No. of
Establishments
1,268
2,196
796
657
4,917
820.140 Handling
- Maintain
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$16,849
$29,174
$21,149
$17,449
$84,622
820.150 Storage(a)
- Maintain
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$16,849
$29,174
$21,149
$17,449
$84,622
Part 820, Subpart
L
Establishment Size, Foreign
Totals
No. of
Establishments
3,876
6,710
2,432
2,007
15,025
820.140 Handling
- Maintain
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$51,485
$89,144
$64,624
$53,319
$258,572
820.150 Storage(a)
- Maintain
procedures
Unit cost saving
$13
$13
$27
$27
Cost Savings
$51,485
$89,144
$64,624
$53,319
$258,572
Total Cost Savings, Subpart L
$686,388
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Subpart M – Records
Subpart M of the previous QS regulation required that manufacturers maintain all records to be legible, and
stored in a manner to prevent deterioration, damage, or loss. Subpart M also required including subcontractor
quality records, if applicable. In addition to medical devices descriptions, complaint files were required to
include the medical devices’ packaging and labeling. Investigative records were also required to determine of
whether there was a device failure, whether the device failure resulted in death or injury, and a description of
corrective action. This final rule replaces the previous requirements with substantially similar requirements in
ISO 13845. We assume that each medical device establishment that complied with both the previous QS

2022-635

regulation and ISO 13485 will require 10% fewer annual labor hours to comply with the provisions of the final
rule that correspond to provisions found in Subpart M of the previous QS regulation, as explained in Section
D.1. of this document. In the sensitivity analysis section, we compare the decrease in compliance effort by 5%
and 25%. Table 48 shows the number of annual labor hours saved for a medical device establishment
complying with the QMSR in this final rule, organized by each provision of Subpart G of the previous QS
regulation.
Table 48. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart G of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart M (Part
820.198)
Small
Medium Large
Very large
820.198 Complaint Files
- Maintain written procedures1
2
2
3
4
2
Comply with Final Rule
1.8
1.8
2.7
3.6
Labor hours saved
0.2
0.2
0.3
0.4

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to complying with the QMSR
in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart M of the previous QS regulation
(see Table 49), and appropriate wage rates and overhead costs (see Table 9) to estimate cost savings from
complying with the QMSR in this final rule for affected establishments.
Table 49. Proportion of Annual Labor by Labor Category, Subpart M of Previous QS Regulation
Labor Category
Part 820, Subpart M
Vice
Upper
Middle
Admin
Technical
Clerical
Provision (Part 820.198)
820.198 Complaint Files
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

20%

Support

Mgmt.

70%

10%

Using the number of hours saved in annual labor (Table 48) by proportion of labor category (Table 49), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart G of the previous QS regulation for affected
entities (see Table 50). Benefits of complying with the QMSR will result in cost savings of approximately

2022-635

$644,000 per year for the affected entities by moving from compliance with both ISO 13485 and the previous
QS regulation to the final rule (see Table 50).
Table 50. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart M of the QS Regulation
Establishment Size, Domestic
Part 820, Subpart
Totals
M (Part 820.198)
Small
Medium
Large
Very Large
No. of
Establishments
1,268
2,196
796
657
4,917
820.198 Complaint
Files
- Maintain written
procedures
Unit cost saving
$27
$27
$40
$53
Cost Savings
$33,699
$58,348
$31,724
$34,899
$158,669
Part 820, Subpart
M
Establishment Size, Foreign
Totals
No. of
Establishments
3,876
6,710
2,432
2,007
15,025
820.198 Complaint
Files
- Maintain written
procedures
Unit cost saving
$27
$27
$40
$53
Cost Savings
$102,971
$178,289
$96,936
$106,637
$484,833
Total Annual Cost Savings, Subpart M
$643,502
Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

Subpart N – Servicing
Subpart N of the previous QS regulation required manufacturers to develop written procedures for managing
servicing operations. The Subpart N requirements also mandated the maintenance of servicing records and the
feedback of device problems detected during servicing into the corrective action system. This final rule replaces
the previous requirements with substantially similar requirements in ISO 13845. We assume that each medical
device establishment that complied with both the previous QS regulation and ISO 13485 will require 10% fewer
annual labor hours to comply with the provisions of the final rule that correspond to provisions found in Subpart
N of the previous QS regulation, as explained in Section D.1. of this document. In the sensitivity analysis
section, we compare the decrease in compliance effort by 5% and 25%. Table 51 shows the number of annual
labor hours saved for a medical device establishment complying with the QMSR in this final rule, organized by
each provision of Subpart N of the previous QS regulation.

2022-635

Table 51. Number of Annual Labor Hours Saved by a Medical Device Establishment to Comply with
Provisions of the Final Rule that Correspond to Subpart N of the Previous QS Regulation
Establishment Size
QS Regulation, Subpart N (Part
820.200)
Small
Medium Large
Very large
Previous820.200 Servicing
- Maintain written procedures1
2
2
3
4
2
Comply with Final Rule
1.8
1.8
2.7
3.6
Labor hours saved
0.2
0.2
0.3
0.4

1. Part 820 Final Rule, 1996.
2. Assume 10% decrease in effort in moving from complying with two similar sets of QS requirements to complying with the QMSR
in the final rule.

We use information from the 1996 final rule codifying the QS regulation in Part 820 to determine
proportions of types of labor needed to comply with each section of Subpart N of the previous QS regulation
(see Table 52), and appropriate wage rates and overhead costs (see Table 9) to estimate benefits of complying
with the QMSR in this final rule for affected establishments.
Table 52. Proportion of Annual Labor by Labor Category, Subpart N of Previous QS Regulation
Labor Category
QS Regulation, Subpart N
Vice
Upper
Middle
Admin
Technical
Clerical
(Part 820.200)
820.200 Servicing
- Maintain written procedures

Source: Part 820 Final Rule, 1996

President

Mgmt.

20%

Support

Mgmt.

70%

10%

Using the number of hours saved in annual labor (Table 51) by proportion of labor category (Table 52), and
by appropriate wage rate and overhead costs (Table 9), we determine the reduced annual labor burden to
comply with provisions of the QMSR corresponding to Subpart N of the previous QS regulation for affected
entities (see Table 53). Benefits of complying with the QMSR will result in cost savings of approximately
$644,000 per year for the affected entities by moving from compliance with both ISO 13485 and the previous
QS regulation to the final rule (see Table 53).
Table 53. Annual Cost Savings of Compliance with the QMSR in the Final Rule Using Corresponding
Provisions of Subpart N of the QS Regulation
QS Regulation,
Establishment Size, Domestic
Subpart N (Part
Totals
820.200)
Small
Medium
Large
Very Large
No. of
Establishments
1,268
2,196
796
657
4,917
820.200 Servicing

- Maintain written
procedures
Unit cost saving
$27
Cost Savings
$33,699
QS Regulation,
Subpart N (Part
820.200)
No. of
Establishments
3,876
820.200 Servicing
- Maintain written
procedures
Unit cost saving
$27
Cost Savings
$102,971
Total Cost Savings, Subpart N

$27
$58,348

2022-635

$40
$31,724

$53
$34,899

Establishment Size, Foreign

$158,669
Totals

6,710

2,432

2,007

$27
$178,289

$40
$96,936

$53
$106,637

Note: Due to rounding, numbers presented in this table may not add up precisely to the totals provided.

15,025

$484,833
$643,502

Subpart O – Statistical Techniques
Subpart O of Part the previous QS regulation required manufacturers to establish and maintain appropriate
statistical techniques and sampling plans to control the quality of processes and product characteristics. These
requirements are consistent with usual practices throughout the medical device industry; therefore, there no
annual compliance cost, or cost savings, is estimated for Subpart O.
Other Benefits of the Final Rule
The above analysis shows that there would be significant annual cost savings in regulatory compliance by
small to large firms within the medical device industry. A benefit that is not quantified in this analysis is a
quicker process for regulatory compliance for medical devices, which would lead to timelier introduction of
safe, effective, high-quality medical devices to patients. More timely access to newly-developed medical
devices has the potential to help patients avoid illnesses, deaths, and costly medical treatments, as well as
improving the quality of life of the consumers. Other benefits include reduced enforcement due to ease of
compliance with one set of quality system management requirements and alignment of programs such as
Medical Device Single Audit Program (MDSAP) with other regulations and standards.
F. Costs of the Final Rule

2022-635

The final rule will impose costs both on the medical device establishments and FDA. All medical
establishments undergo a one-time cost to learn the rule. In addition to learning the rule’s requirements, medical
device establishments that are not in compliance with ISO 13485 when the final rule is implemented will
undergo the following costs:
-

One-time cost of initial training of regulatory compliance expert,

One-time cost of initial updating of establishment’s information technology, and

One-time cost of initial update of establishment documents related to policy and procedures.

One-Time Costs to Learn the Rule
We model the one-time learning costs as the time required by medical device establishments’ regulatory
affairs expert to access and read the final rule. We estimate that a regulatory affairs expert would incur a burden
between 15 and 30 minutes to access the rule and would read the provisions at a rate of 200 to 250 words per
minute (wpm). The preamble and codified regulatory text are approximately 30,000 words. We estimate that it
would take between 2 hours (30,000 words ÷ 250 wpm x 1 hour/60 mins), and 2.5 hours (30,000 words ÷ 200

wpm x 1 hour/60 mins) (average: 2.22 hours) for a regulatory affairs expert to read and understand the rule.

We estimate the mean hourly wage of a regulatory affairs expert using mean hourly wages reported in
the Bureau of Labor Statistics, Occupational Employments Statistics, May 2022 for a lawyer (SOC 23-1011;
$78.74) which is doubled ($157.48) to account for benefits and overhead costs. Applying the fully-loaded mean
hourly wage to the hourly burdens described previously, we obtain a cost of between $378 and $457 (average:
$409) for a regulatory affairs expert to access and read the final rule (i.e., (average of 15 and 30 minutes: 22.5
minutes or 0.375 hours + 2.22 hours) x $157.48 per hour). The total access and learning cost for all affected
entities (25,294) is between $9.57 million ($378/establishment x 25,294 establishments) and $11.56 million
($457/establishment x 25,294 establishments) (average: $10.35 million). Table 54 breaks down the cost of
learning the rule for th very small establishments (5,352; $2.19 million), and small to very large establishments
(19,942; $8.16 million). We assume that each establishment would incur the access and reading costs the first
year following publication of the rule. Consequently, over 10 years at a discount rate of 7 percent, we estimate

2022-635

the annualized one-time learning cost for all establishments (25,294 = 5,352 + 19,942) is approximately $1.29
million per year ($272,208 + $1,104,306). When we assume a discount rate of 3 percent, the annualized onetime cost is approximately $1.15 per year ($241,876 + $901,284) (see Table 54). The 10-year horizon period of
the one-time cost annualizations considers that the final rule will become effective 2 years following its
publication date.
One-Time Cost of Initial Training of Regulatory Compliance Expert
We believe medical device establishments that currently comply with ISO 13485 already have a regulatory
compliance expert who is familiar with the ISO standard. Therefore, these costs are attributed to the very small
domestic medical device establishments (5,352). We expect that the person who directs regulatory compliance
of a medical device establishment that currently is not in compliance with ISO 13485 would, at a minimum,
attend a 3-day course to become knowledgeable of differences between Part 820 and ISO 13485. A compliance
training organization offers a 3-day course for non-members at $2,796 per person. 1 A 3-day training on ISO
13485 for regulatory compliance experts of very small domestic medical device manufacturing establishments
(5,352) who would transition to the final rule is approximately $15 million ($2,796/establishment x 5,352
establishments) (see Table 54). The training course includes a copy of the ISO 13485 for the participants. We
assume that each establishment would incur this cost the first year following publication of the rule.
Consequently, over 10 years at a discount rate of 7 percent, we estimate the annualized one-time document
update is approximately $1.86 million per year (see Table 54). When we assume a discount rate of 3 percent,
the annualized one-time cost is approximately $1.66 million per year over 10 years (see Table 54). The 10-year
horizon period of the one-time cost annualizations considers that the final rule will be implemented 2 years
following its publication date.
One-Time Cost of Initial Updating of Medical Device Establishments’ Information Technology

1 Design Control Requirements – Integrating the Quality System Regulation. Source: http:// aami.org/, March 2023. Priced at $2,935;
deflated to March 2022 prices at $2,795.64 to for consistency with cost saving estimates which are calculated in 2022 dollars.

2022-635

We believe medical device establishments that currently comply with ISO 13485 have already an
updated information technology in order to comply with the ISO standard. Therefore, these costs are attributed
to the very small domestic medical device establishments (5,352). We expect that a very small domestic
medical device establishment that currently does not comply with ISO 13485 will update its compliance
infrastructure, at a minimum, by purchasing specialized software that would guide the establishment in
complying with the final rule. The least expensive option for ISO 13485 specialized software which requires a
one-time payment is listed for $690. 2 The purchase of such software for all small medical device establishments
(5,352) is approximately $3.7 million ($690/establishment x 5,352 establishments) (see Table 54). We assume
that each establishment would incur this cost the first year following publication of the rule. Consequently, over
10 years at a discount rate of 7 percent, we estimate the annualized one-time document update is approximately
$460,000 per year (see Table 54). When we assume a discount rate of 3 percent, the annualized one-time cost is
approximately $408,000 per year over 10 years (see Table 54). The 10-year horizon period of the one-time cost
annualizations considers that the final will be implemented 2 years following its publication.
One-Time Cost of Initial Update of Establishment Documents Related to Policy and Procedures
We believe medical device establishments that currently comply with ISO 13485 have already updated
their establishments’ documents related to policy and procedures associated with the ISO provisions. Therefore,
these costs are attributed to the very small domestic medical device establishments (5,352). We expect that it
would take 40 labor hours for the establishment’s regulatory affairs expert to make changes and updates to the
establishment’s documents pertaining to policy and procedure changes as a result of the final rule. Using the
fully-loaded mean hourly wage rate of $157.48 per hour (see above), we estimate that it would cost
approximately $6,300 (40 hours x $157.48/hour) for a very small domestic medical device establishment to
conduct this activity. The total cost of updating documents related to policy and procedures for small medical
device establishments (5,352) is approximately $33.7 million ($6,300/establishment x 5,352 establishments)
(see Table 54). We assume that each establishment would incur this cost the first year following publication of

2 Pre-loaded ISO 13485:2016 & 21 CFR 820 template documentation, IMSXPRESS. Source: http://www.imsxp.com/

2022-635

the rule. Consequently, over 10 years at a discount rate of 7 percent, we estimate the annualized one-time
document update is approximately $4.2 million per year (see Table 54). When we assume a discount rate of 3
percent, the annualized one-time cost is approximately $3.8 million per year over 10 years (see Table 54). The
10-year horizon period of the one-time cost annualizations considers that the final rule will be implemented 2
years following its publication.
Table 54. Summary of One-Time Costs for Medical Device Establishments
Annualized Cost
Affected
(10-year horizon)
Activity
One-Time Cost
Entities
3%
Very Small Domestic Medical Device Establishments
Learning
$2,188,906
the rule
5,352
$241,876
Initial
training
5,352
$14,963,768
$1,653,511
IT update
5,352
$3,692,775
$408,055
Documents
$3,725,250
update
5,352
$33,712,363
Total cost, very small
est.
$54,557,812
$6,028,693
Small to Very Large Domestic and Foreign Medical Device Establishments
Learning
the rule
19,942
$8,156,340
$901,284
Total cost, small to very
large est.
$8,156,340
$901,284
Total one-time costs
$62,714,152
$6,929,976

7%
$272,208
$1,860,865
$459,226
$4,192,403
$6,784,702
$1,014,306
$1,014,306
$7,799,008

Note: The criterion for “very small” is an establishment that has an annual revenue of less than $0.5 million. These establishments
encompass categories of “establishments with less than 5 employees,” and “establishments with 5 to 9 employees” in the 2020 County
Business Pattern database.

FDA costs
As part of transitioning from managing the QS regulation program to the QMSR as described in the final
rule, FDA plans to provide initial training for its staff in the Office of Medical Device and Radiological Health
Operations (OMDRHO), update its IT infrastructure, and update documents related to policies and procedures.
One-Time Cost of Initial training of OMDRHO staff
Initial training of the OMDRHO staff includes the following:
-

A 5-day (40 hours) AAMI course on the QS regulation and ISO 13485 for 196 staff members: AAMI
offers its training course (for maximum of 50 students/course) for $38,750. FDA would need 4 courses

2022-635

to accommodate its 196 staff members at a cost of $155,000 (4 courses x $38,750/course) (see Table
55). Average weighted hourly wage rate of OMDRHO staff is estimated at $52.46 per hour (see Table
56) which is doubled ($104.92) to account for benefits and overhead costs. Estimated cost of wages of
OMDRHO staff to attend AAMI course is $822,542 (40 hours of training x 196 staff members/training x
$104.92/hour) (see Table 55). In addition, OMDRHO estimates that travel and per diem cost to attend
the AAMI Standard course at $1,600 per person assuming that in-person training is necessary.
Therefore, the travel cost of 196 FDA staff members to attend the AAMI course is $313,000 (196 staff
members x $1,600/staff member) (see Table 55). The total initial one-time cost of AAMI Standard
course is estimated at approximately $1.3 million (see Tables 55 and 58).
Table 55. Initial One-Time Cost of AAMI Standard Course
Activity
Hours of Number of
Average
Total
Training staff/units
wage/unit price
Training Time Cost
40
196
$104.92
$822,542
Training Instruction and
40
4
Development
$38,750
$155,000
Travel Expenses ORA to
40
196
Training
$1,600
$313,600
Total
$1,291,142
Table 56. OMDRHO Staff Number and Wages
Position/GS Level
Average
Number
Hourly Wage
of Staff
CSO GS-7
$27.50
20
CSO GS-9
$33.64
8
CSO GS-11
$40.70
20
CSO GS-12
$48.78
30
CSO GS-13
$58.01
70
CSO GS-14 (NE)
$68.55
2
CO GS-13
$58.01
14
PE GS-13
$60.83
2
SCSO GS-13/14
$64.83
17
GS 14 Managers
$68.55
8
GS 15+Managers
$80.63
5
Total
196
Mean Weighted Average
$52.46
Mean Wage + Benefits
$104.92

2022-635

A 4-day (32 hours) AAMI Audit course for 150 staff members (a subset of the 196 staff members):
AAMI offers its Audit training course (for maximum of 50 students/course) for $35,000. FDA would
need 3 courses to accommodate its 150 staff members at a cost of $105,000 (3 courses x
$35,000/course) (see Table 57). OMDRHO estimates the average hourly wage rate of a participant of
that of a GS-12 ($48.78/hour) (see Table 56) which is doubled ($97.56) to account for benefits and
overhead costs. Estimated cost of wages of OMDRHO staff to attend AAMI Audit course is $468,288
(32 hours of training x 150 staff members/training x $97.56/hour) (see Table 57). In addition,
OMDRHO estimates that travel and per diem cost to attend the AAMI course at $1,300 per person.
Therefore, the travel cost of 150 FDA staff members to attend the AAMI Audit course is $195,000 (150
staff members x $1,300/staff member) (see Table 57). The total initial one-time cost of AAMI Audit
course is estimated at $768,288 (see Tables 57 and 58).
Table 57. Initial One-Time Cost of AAMI Audit Course
Activity
Hrs of
Number of
Average
Training
staff/units
wage/unit price
Training Time Cost
32
150
$97.56
Training Instruction and
32
3
Development
$35,000
Travel Expenses ORA to
32
150
Training
$1,300
Total

Total
$468,288
$105,000
$195,000
$768,288

A 3-day (24 hours) training by FDA’s Center for Devices and Radiological Health (CDRH) with FDA’s
Office of Regulatory Affairs (ORA) for 196 staff members: Using the fully-loaded weighted mean
hourly wage of all OMDRHO staff member ($104.92), we estimate the cost of training 196 staff
members for this in-house training at $493,525 (24 hours/staff member x $104.92/hour x 196 staff
members) (see Table 58).

A 3-day (24 hours) ORA Inspection Training for 175 staff members: Using the fully-loaded weighted
mean hourly wage of OMDRHO staff member ($104.92), we estimate the cost of training 175 staff

2022-635

members for this in-house training at $440,648 (24 hours x $104.92/hour x 175 staff members) (see
Table 58).
-

3-day (24 hours) ORA Enforcement/Compliance Training 17 staff members: We use the mean hourly
wage of OMDRHO’s COs and DCBs at the rate of GS-14, $68.55 per hour, and double it ($137.10 per
hour) to account for benefits and overhead costs. We estimate the cost of training 17 staff members for
this in-house training at $55,937 (24 hours/staff member x $137.10/hour x 17 staff members) (see Table
58).

Other One-Time Initial Training Costs
FDA estimates that it would cost $12,000 to conduct state contractor training for 7 inspectors in
California and Texas (see Table 58).
Initial Cost of Updating FDA’s Information Technology
Updating FDA’s current software and other IT-related resources include the following:
-

eNspect citation re-write and verification: The citation re-write and verification will be conducted by 3
FDA staff members for 800 labor hours at average hourly wage rate of a staff member between GS 13
and GS 14 pay levels, or at $64.83 per hour (see Table 56). Using the fully-loaded mean hourly wage
rate ($129.66/hour = $64.83/hour x 2), we estimate that this IT activity costs $103,728 (3 staff members
x 800 hours/3 staff members x $129.66/hour) (see Table 58).

eNspect EIR re-write/formatting: The re-write/formatting of the eNspect EIR system requires 200 hours
of one staff member at pay level of $67.98 per hour. Using the fully-loaded mean hourly wage rate
($129.66), we estimate that this IT activity costs $25,932 (1 staff member x 200 hours/staff member x
$129.66/hour) (see Table 58).

ORADSS report and data collection re-write: The re-write of ORADSS report and data is expected to
require 200 hours of one staff member with a wage rate of $64.83 per hour. Using the fully-loaded mean
hourly wage rate $129.66 per hour, we estimate that this IT activity costs $25,932 (1 staff member x 200
hours/staff member x $129.66/hour) (see Table 58).

2022-635

One-Time Cost of Initial Update of FDA Documents Related to Policy and Procedures
We expect that it would take 300 labor hours for 3 staff members with a wage rate of $64.83 per hour to
make changes and updates to FDA documents pertaining to policy and procedure changes as a result of the
final rule. Using the fully-loaded mean hourly wage rate of $129.66 per hour, we estimate that it would cost
$38,898 (300 staff hours x $129.66/hour) to conduct this one-time activity (see Table 58).
Summary of FDA Costs
Table 58 provides a summary of FDA costs described above. The total initial on-time cost for FDA to
train its employees and update its IT infrastructure and documents and procedures related to the final rule are
approximately $3.3 million. We assume that FDA would incur these initial costs the first year following
publication of the rule. Consequently, over 10 years at a discount rate of 7 percent, we estimate the annualized
initial FDA costs at approximately $404,000 per year. When we assume a discount rate of 3 percent, the
annualized one-time costs are at approximately $360,000 per year over 10 years. The 10-year horizon period of
the one-time FDA cost annualizations considers that the final will be implemented 2 years following its
publication date.
Table 58. Summary of FDA Costs
Activity
Training
AAMI Standards Course
AAMI Audit Course
CDRH Training with ORA
ORA Inspection Training (CSO, SCSO & DIB)
ORA Enforcement/Compliance Training (CO & DCB)
State Contractors Training (CA & TX)
IT Update
eNSpect Citation Re-write (by GS 13/14s) & Verification
eNSpect EIR Re-write/Formatting (by GS13/14s)
ORADSS Report (data collection) Re-write (by GS 13/14)
Documents Update
IOM/CPGM/RPM/SOP Changes and Updates (review)
Total
Annualized 10-year, 7%
Annualized 10-year, 3%

Cost
$1,291,142
$768,288
$493,525
$440,648
$55,937
$12,000
$103,728
$25,932
$25,932
$38,898
$3,256,030
$404,914
$359,795

2022-635

G. Distributional Effects
There are no transfer payments or differential effects across income groups, ethnic groups, geographical
regions, gender, and age groups.
H. International Effects
Throughout this FRIA, we assume that all foreign medical device establishments registered with the FDA
that are larger than very small (less than $500K) in size, currently comply with both the current Part 820 and
ISO 13485. Therefore, the final rule would benefit foreign medical device establishments through cost savings
from the reduced annual compliance effort to create and maintain a single quality system. For this analysis, we
estimate 15,025 foreign medical device establishments by different employee size categories (see Table 8b) will
experience these cost savings. In Section E, we estimate annual cost savings of approximately $435 million for
foreign medical device establishments that currently comply with both the current Part 820 and ISO 13485.
Cost savings estimated for foreign medical device establishments in Section E are re-presented in Table 59. The
annual cost savings to foreign establishments ($435M) is approximately 75% of total annual cost savings
($578M) of the final rule.
Table 59. Annual Cost Savings for Foreign Medical Device Establishments
Part 820 Subpart
A
B
C
D
E
F
G
H
I
J
K
L
M
N

Reference
N/A
Table 13b
Table 17b
Table 21
Table 24b
Table 28
Table 31b
Table 35
Table 38
Table 41
Table 44
Table 47
Table 50
Table 53

Cost Savings

N/A
$6,541,693
$405,789,803
$484,833
$17,218,536
$176,294
$1,793,049
$258,572
$484,833
$484,833
$258,572
$517,145
$484,833
$484,833

O
N/A
Annual Cost Savings, Foreign Establishments
Annual Cost Savings, All Establishments

2022-635

N/A
$434,977,829
$577,330,707

The cost to foreign medical device establishments registered with the FDA is the labor cost of medical
device establishments’ regulatory affairs experts to access and read the final rule. In Section F, we estimated
that, on average, it would cost a medical device establishment $370 to read and learn the final rule. Therefore,
the cost of reading and learning the rule for all foreign establishments is approximately $6.15 million
($409/establishments x 15,025 establishments). We estimate the net cost savings to foreign medical device
establishments registered with FDA at approximately $429 million ($435 million - $6 million).
I. Uncertainty and Sensitivity Analysis
In this section, we conduct sensitivity analyses of the assumption of decreased burden (cost savings) of
establishments which are currently complying with both the current Part 820 and ISO 13485.
Decrease of Compliance Effort
In the above analysis, we assume the effort of a medical device establishment that complies with both the
current Part 820 and ISO 13485 would decrease by 10% by moving to complying with the final rule. We now
use different assumptions in proportion of reductions in burden rate, 5% and 25%, to measure the lower and
upper bound estimates of these cost savings.
Industry costs and FDA costs under each burden rate (i.e., 5%, 10%, and 25%) remains the same.
Comparison of effect of assumption rates shows that net savings of the final rule varies between approximately
$262 million and approximately $1,341 million ($532M used as the primary estimate in main analysis) (see
Table 60).
Table 60 – Comparison of Effect of Assumption Rates for Increase/Decrease of Burden of Effort to
Comply with the Final Rule
Increase/Decrease Burden Effort
Cost
5%
10%
25%
Saving/Cost
Lower Estimate
Primary Estimate
Upper Estimate
Cost
Savings –
Industry
$269,780,704
$539,561,409
$1,348,903,521

Costs Industry
Costs –
FDA
Net Cost
Savings

2022-635

$7,799,008

$404,914

$261,576,783

$531,357,487

$1,340,699,600

Note: These annual costs are discounted at 7% for a 10-year horizon. The 10-year horizon period of the cost annualizations considers
that the final rule will be implemented 2 years following its publication date.

J. Analysis of Regulatory Alternatives to the Final Rule
1. Option One: Keep the QS Regulation as an Option for Entities who Prefer It
If the QS regulation were maintained as an option—though not a requirement— for compliance with FDA’s
CGMP requirements for medical devices some, but not all, of the estimates appearing in the preceding analysis
would change. Rule-induced cost savings would be the same, but the costs incurred by entities not already
complying with ISO 13485 requirements would be avoided, as discussed above. Additionally, there would be
unquantified costs to FDA relative to the rule as written, and potentially to some regulated entities, as a result of
incomplete streamlining and harmonization of expectations being associated with greater scope for confusion.
This regulatory option would be inconsistent with FDA’s goal of harmonizing the medical device CGMP
requirements with ISO 13485. No other dual systems are considered.
2. Option Two: Finalize the Proposed Action
The final rule will have an effective date 2 years from the date of its publication in the Federal Register.
Under this option, we compare effect of postponement of the effective date of the final rule by an additional two
years. We compare cost savings and costs of the final rule if the rule would extend its effective date by 2
additional years. Table 61 indicates that the net cost savings of a 2-year postponement of the effective date of
the final rule would be decreased from approximately $532 million to approximately $465 million.
Table 61 – Postponement of Implementation Date of the Final Rule – Cost Savings and Costs
Implementation Date
Cost/Cost Saving
No Delay
Two Year Delay
Cost Savings – Industry
$539,561,409
$471,273,830
Costs – Industry
$7,799,008
$6,811,956

Costs - FDA
Net Cost Savings

$404,914
$531,357,487

2022-635

$353,667
$464,108,208

III. Final Small Entity Analysis
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any
significant impact of a rule on small entities. According to the Small Business Administration’s (SBA’s)
standards for different sectors of medical device industry, the great majority of medical device establishments
included in our analysis are considered ‘small entities.’ Based on data provided by the U.S. Census Bureau for
selected medical device establishments (see Table 3), approximately 99% of all medical device establishments
would be considered small entities by the SBA. Table 62 includes examples of ‘small business’ criteria for
different types of medical device establishments. We believe that most medical device establishments have
fewer employees than SBA’s thresholds allow (see Table 62). Therefore, considering SBA’s standard for small
business, the final rule would result in a net annual cost savings of over $500 million (see Table 63).
In this analysis, we considered medical device establishments that are considered ‘very small,’ entities
that have annual revenue of less than $0.5M and typically have 9 employees or less. We assumed that very
small domestic medical establishments do not currently conform to the ISO 13485 standard. Table 63 includes
the estimated annualized burden to medical device establishments based on whether they are very small or not.
Annualized burden of costs for a very small establishment is estimated at approximately $1,200 (see Table 63).
Net annualized cost savings for other medical device establishments is estimated, on average, at approximately
$27,000 (see Table 63). As noted before, we believe that other benefits may accrue to medical device
establishments as a result of the final rule. The harmonization of medical device CGMP requirements with ISO
13485 as reflected in the final rule will result in a smaller regulatory compliance burden and potentially quicker
access for medical devices to enter the market. Considering the number (5,352) and annual burden ($1,268 cost)
of very small establishments and those of small to very large establishments (19,942 establishments, $27,005

2022-635

cost saving), we certify that the final rule will not have a significant economic impact on a substantial number
of small entities. This analysis, as well as other sections in this document, serves as the Final Regulatory
Flexibility Analysis, as required under the Regulatory Flexibility Act.
Table 62. Small Business Administration Threshold for a Small Business Designation
NAICS
Number of
Establishment description
Code
Employees
325413 In-vitro diagnostic substance manufacturing
1,250
334510 Electromedical and electrotherapeutic apparatus manufacturing
1,250
334517 Irradiation apparatus manufacturing
1,200
339112 Surgical and medical instrument manufacturing
1,000
339113 Surgical appliance and supplies manufacturing
800
339114 Dental equipment and supplies manufacturing
750
339115 Ophthalmic goods manufacturing
1,000
Source: Small Business Administration, Table of Small Business Size Standards.
Link: Table of Small Business Size Standards. U.S. Small Business Administration. March 17, 2023.
Last accessed: November 2023

Table 63 – Annualized Costs and Cost Savings of Medical Device Establishments Based on Size
Size
Cost/Cost Saving
Very Small
Small to Very Large
Total Costs
$6,784,702
$1,014,306
Total Cost Savings
$539,561,409
No. of Establishments
5,352
19,942
Cost/Establishment
$1,268
Cost Saving/Establishment
$27,005
1. Costs are annualized for a 10-year period, 7% discount rate (see Table 54)
Note: Very small establishment has revenue of less than $0.5M per year.

Effect of Final Rule on Competitive Fairness in the Medical Device Industry
Potentially, foreign medical device establishments that currently do not export their products to the U.S.
may choose to comply with the final rule, when implemented, and export their products to the U.S. These
foreign medical device establishments will face the same one-time costs that all current foreign and domestic
establishments face (including those designated ‘very small’). In addition to prospective foreign medical device
establishments, current domestic establishments (small to very large) may fill the void of the ‘very small’
domestic establishments who may choose to exit the industry. In the face of new costly rulemaking, there is a
potential for certain establishments to decide to exit the industry, new establishments to enter the industry, or

2022-635

both. In the case where certain domestic establishments choose to exit the industry, there is a potential for
existing domestic or foreign establishments to occupy the market of the exiting establishments or new
establishments to enter the market.

IV. References
1. Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System
Regulation, Food and Drug Administration, Federal Register Vol. 61 No.195, 10/7/1996, pgs. 5260252662.
2. Economic Analysis of Proposed Revisions to the Good Manufacturing Practices Regulation for Medical
Devices, Final Report, Eastern Research Group, Inc., November 1993.
3. Economic Analysis of Proposed Revisions to the Good Manufacturing Practices Regulation for Medical
Devices, Addendum, Eastern Research Group, Inc., August 1996.

File Type	application/pdf
File Title	Medical Devices; Quality System Regulation Amendments
Subject	Docket No. FDA-2021-N-0507
Author	Food and Drug Administration
File Modified	2024-02-06
File Created	2024-02-02