0485 Device Labeling SSA 2021 091721

UNITED STATES FOOD & DRUG ADMINISTRATION
Medical Device Labeling Regulations
OMB Control No. 0910-0485 – Revision
SUPPORTING STATEMENT
Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency or we)
implementation of medical device labeling requirements governed by section 502 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in Agency regulations and
discussed in Agency guidance. Medical device labeling requirements provide for the label or
labeling of a medical device so that it is not misbranded and subject to regulatory action. Certain
provisions under section 502 require manufacturers, importers, and distributors of medical
devices to disclose information about themselves or the devices on the labels or labeling for the
devices. Section 502(b) of the FD&C Act requires that, for packaged devices, the label must
bear the name and place of business of the manufacturer, packer, or distributor as well as an
accurate statement of the quantity of the contents. Section 502(f) of the FD&C Act requires that
the labeling for a device must contain adequate directions for use. Exemptions from labeling
requirements may be granted if the agency determines that the adequate directions for use
labeling requirements are not necessary in that particular case, as it relates to protection of the
public health.
Implementing regulations in parts 800, 801, and 809, and associated regulations in parts 660 and
1040 (21 CFR parts 660, 800, 801, 809 and 1040) set forth content and format requirements
manufacturers, importers, and distributors of medical devices must disclose about themselves or
the devices, on the label or labeling for the devices to health professionals and consumers.
Provisions found in part 801, subpart B pertaining to labeling requirements for Unique Device
Identification are currently approved under OMB control number 0910-0720 and not covered in
this information collection request. Information collection associated with labeling requirements
for Over-the-Counter (OTC) Devices are found in part 801, subpart C, and cover principal
display panel; statement of identity; declaration of net quantity of contents; and certain warning
statement elements. Information collection associated with exemptions from adequate directions
for use and other exemptions are found in part 801, subparts D and E, respectively. Information
collection associated with special labeling requirements applicable to specific devices are found
in part 801, subpart H. We also include information collection associated with labeling for in
vitro diagnostic products for human use, as set forth in part 809, subpart B.
Section 534 of the FD&C Act (21 U.S.C. 360kk) authorizes the FDA to prescribe performance
standards for electronic products to control the emission of electronic product radiation to protect
public health and safety. The performance standards may include requirements for warning

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signs and labels. Accordingly, FDA promulgated regulations in 21 CFR part 1040, Performance
Standards for Light-Emitting Products. Section 1040.20(d) provides that manufacturers of
sunlamp products and ultraviolet lamps are subject to the specific labeling in addition to labeling
required by part 801.
Section 502(u) (21 U.S.C. 352(u)) requires single use devices (SUDs), both new and
reprocessed, to bear prominently and conspicuously the name of the manufacturer, a generally
recognized abbreviation of such name, or a unique and generally recognized symbol identifying
the manufacturer. Under 502(u), if an original SUD, or an attachment to it, prominently and
conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to
identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the
device or attachment to the device. If an original SUD does not prominently and conspicuously
bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse may
identify itself using a detachable label that is intended to be affixed to the patient record. To
assist respondents with information collection associated with these statutory provisions, we
developed the guidance document entitled “Compliance with Section 301 of the Medical Device
User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices.” The guidance document identifies circumstances in
which the name or symbol of the original SUD manufacturer is not prominent and conspicuous,
as used in section 502(u) of the FD&C Act. However, the guidance does not contain additional
information collections.
Finally, regulations in 21 CFR parts 660, 801, and 809 now explicitly allow for the use in
medical device labeling of stand-alone symbols (not accompanied by explanatory text adjacent to
the symbol) established in an SDO-developed standard. The specific regulatory provisions are
set forth in 21 CFR part 660, additional standards for diagnostic substances for laboratory
standards for biological products, subparts A, C, D, E, and F and in the general medical device
labeling regulations part 801, subpart A and part 809, subpart B. Guidance we previously issued
in this regard has been withdrawn, however we retain estimates we attribute for respondents who
submit symbols glossaries with labeling for medical devices consistent with the applicable
regulations. Accordingly, we are requesting OMB approval of the information collection
provisions included in the applicable regulations, found in the associated guidance document,
and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The primary users of the information disclosed on the label or in the labeling for devices are the
health professionals who use or prescribe the device or the lay consumers who use the device.
The purpose of the information collections is to ensure sufficient information for safe and
effective use of medical devices. FDA may also use the information to determine whether there
is reasonable assurance of the safety and effectiveness of the device for its intended use. Failure
of the manufacturer, packer, or distributor to label its products in accordance with section 502 of
the act may result in the product being misbranded under the act thereby subjecting the firm and
the product to regulatory action. Respondents are private sector for-profit businesses.

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It is essential to require the specific identification of reprocessed SUDs to ensure that physicians,
nurses, users, and hospital administrators know that a device was reprocessed. The intent of the
labeling requirement is to ensure that physicians, hospital staff, and patients can identify the
reprocessor of a SUD when an adverse event or risk to health information should be attributed to
the responsible manufacturer. The information and records generated under this labeling
requirement can be used to associate a particular device with a particular manufacturer. This is
especially important in the event of a recall, warning, patient injury, or product malfunction.
Section 519 of the FD&C Act requires manufacturers to report patient injuries and product
malfunctions to FDA, and device user facilities to report these adverse events to FDA or the
manufacturer. FDA’s post-marketing surveillance program cannot work as intended unless
health care providers, original manufacturers, device reprocessors, and FDA can readily and
accurately identify when a SUD has been reprocessed. The lack of specific labeling to identify
reprocessed devices may lead to incomplete and inaccurate reporting of patient injuries and
product malfunctions involving reprocessed SUDs, particularly in an instance where a
reprocessed device bears only the name or mark of the original manufacturer. The lack of
adequate labeling to identify a reprocessor undercuts the purpose and effectiveness of section
519 of the FD&C Act and FDA’s medical device reporting regulations such that FDA would
lacks accurate information of the postmarket safety and effectiveness of reprocessed SUDs.
Failure of the reprocessor to label the SUD; whether on the device itself, an attachment to the
device, or with a detachable label; may result in the product being misbranded under the FD&C
Act, subjecting the firm and the product to regulatory action. Any SUD reprocessed from an
original device that the original manufacturer has prominently and conspicuously marked must
be prominently and conspicuously remarked with the reprocessor’s name, a generally recognized
abbreviation of its name, or a unique and generally recognized symbol for it.
The information collection will be used by individuals, by the private and public institutions
providing healthcare, and by FDA post-market surveillance analysts.
Various symbols with accompanying text have been used in health product labeling for several
years, both on package labels and within other labeling documents, such as the instructions for
use. The rule continues to allow the use of symbols, including standardized symbols, on device
labeling when the symbols are accompanied by explanatory adjacent text.
The likely respondents for this collection of information are domestic and foreign device
manufacturers who plan to use stand-alone symbols on the labels and/or labeling of their devices
(private sector for-profit businesses and not-for-profit institutions).
3. Use of Improved Information Technology and Burden Reduction
Manufacturers, packers, and distributors may use any appropriate information technology to
develop and distribute the required labeling. While paper copies are often used for labeling
accompanying a device, manufacturers may use appropriate information technology to keep
records required by the labeling regulations.

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Section 502(f) of the FD&C Act (as amended) authorizes the use of electronic labeling, rather
than the traditional paper labeling. Specifically, for prescription devices intended for use in
health care facilities or by a health care professional and labeling for in vitro diagnostic devices
intended for use by health care professionals or in blood establishments may provide labeling for
those devices solely in electronic form, so long as the labeling complies with all applicable laws
and the manufacturer affords users the opportunity to request the labeling in paper form and
promptly provides such labeling to requestors without additional cost.
We estimate 95% of respondents will use electronic means to fulfill the information collection.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
Using the guidelines set by the Small Business Administration on what constitutes a small
business (for manufacturing, a small business cannot exceed 500 employees), we estimate that
approximately 95% of U.S. medical device manufacturing establishments are considered small
businesses.
The requirements in these regulations are the minimum requirements for complying with the
provisions of the act. In most cases, the information that is required to be disclosed is
information that is available to the firm, including a small business, as a normal course of its
doing business.
FDA aids small business and manufacturers to comply with applicable statutes and regulations
by providing guidance and information through the Division of Industry and Consumers
Education (DICE) within the Center for Devices and Radiological Health. DICE provides
workshops, onsite evaluations, and other technical and nonfinancial assistance to small
manufacturers. The workshops make available publications and educational materials, which
include medical device establishment and listing requirements. DICE also maintains a toll-free
800 telephone number and a website that firms may use to obtain regulatory compliance
information.
6. Consequences of Collecting the Information Less Frequently
The information collection is consistent with applicable statutory and regulatory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency

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In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of July 13, 2021 (86 FR 36752). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift has been provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
In preparing this supporting statement, we consulted our Privacy Office to ensure appropriate
identification and handling of information collected. Although personally identifiable
information (PII) is collected, it is in the context of the subject individuals’ professional capacity
and the FDA-related work performed for their employer (e.g., point of contact at a regulated
entity). The PII collected is name, email address, telephone number, and address. We have
determined that although PII is collected it is not subject to the Privacy Act of 1974 and the
particular notice and other requirements of the Privacy Act do not apply. Specifically, neither
FDA or any contractor uses names or any other personal identifier to routinely retrieve records
from the information collected. Through appropriate design, FDA has limited submission fields
and minimized the PII collected to protect the privacy of the individuals.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to
government documents. However, FOIA provides certain exemptions from mandatory public
disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest possible
disclosure of records to the public, consistent with the rights of individuals to privacy, the
property rights of persons in trade and confidential commercial or financial information.
Information that is made available in labeling is, by its nature, public information. Information
that is trade secret or confidential is subject to FDA’s regulations on the release of information,
21 CFR Part 20.
11. Justification for Sensitive Questions
This information collection does not include any questions that are of a sensitive nature, such as,
sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered
private.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

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Table 1.--Estimated Annual Reporting Burden1
21 CFR Citation
No. of
No. of
Total Annual
Average
Total
Respondents
Responses per
Responses
Burden per
Hours
Respondent
Response
Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent
Red Blood Cells; Hepatitis B Surface Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling; Part
809, subpart B: Labeling
Symbols glossary - 660.2;
3,000
1
3,000
1
3,000
antibody to Hepatitis B surface
antigen requirements, 660.28;
blood grouping labeling, 660.35;
reagent red blood cell labeling,
660.45, hepatitis B surface
antigen labeling, 660.55; antihuman globulin labeling, 801.15;
medical devices labeling and use
of symbols; 809.10, labeling for
in vitro diagnostic products

There are no capital costs or operating and maintenance costs associated with this collection of
information.

Our figures are based on data from the FDA Unified Registration and Listing System and the
OASIS shipment information. FDA regulations allow for the use of stand-alone graphical
representations of information, or symbols, in the labeling for the medical devices and diagnostic
substances for laboratory standards, if the symbol has been established in a Standards
Development Organization (SDO) developed standard, provided that such symbol is explained in
a symbols glossary that is included in the labeling for the medical device and otherwise complies
with section 502 (misbranding) of the FD&C Act. These labeling requirements are set forth in
21 CFR part 660, subparts A, C, D, E, and F, in the additional standards for diagnostic
substances for laboratory standards for biological products, including: general requirements (21
CFR 660.2), using antibody to Hepatitis B surface antigen (21 CFR 660.28), blood grouping
reagent (21 CFR 660.35), reagent red blood cells (21 CFR 660.45), Hepatitis B surface antigen
(21 CFR 660.45); and anti-human globulin (21 CFR 660.55). The requirements are also found in
the general medical device labeling regulations (part 801, subpart A) and in the in vitro
diagnostic product labeling regulations (part 809, subpart B).
Table 2.--Estimated Annual Recordkeeping Burden1,2
21 CFR Citation
No. of
No. of
Total
Average
Total
Recordkeepers
Records per
Annual
Burden per
Hours
Recordkeeper
Records
Recordkeeping
Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements
for Specific Devices
Processing, labeling, or
7,500
887
6,652,500
0.5 (30
3,326,250
repacking agreement; 801.150
minutes)
Impact resistant lenses; invoices,
shipping documents, and records
of sale or distribution;
801.410(e) and (f)
Hearing aid records; 801.421

1,591

47,050

74,856,550

0.0008 (0.048
minutes)

59,885

10,000

160

1,600,000

0.25 (15
minutes)

400,000

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Menstrual tampons, sampling
plan for measuring absorbency;
801.430(f)
Latex condoms; justification for
the application of testing data to
the variation of the tested
product; 801.435(g)
Total

33

11

363

80

29,040

51

3.65

186

1

186

83,109,599

3,815,361

1

There are no capital costs or operating and maintenance costs associated with this collection
of information.
2
Numbers have been rounded.
As set forth in § 801.150(a)(2) (21 CFR 801.150(a)(2)), device manufacturers are required to
retain a copy of the agreement containing the specifications for the processing, labeling, or
repacking of the device for 2 years after the final shipment or delivery of the device. Section
801.150(a)(2) requires that copies of this agreement be made available for inspection at any
reasonable hour upon request by any officer or employee of the Department of Health and
Human Services (HHS). In § 801.410(e) (21 CFR 801.410(e)) copies of invoices, shipping
documents, and records of sale or distribution of all impact resistant lenses, including finished
eyeglasses and sunglasses, are required to be maintained for 3 years by the retailer and made
available upon request by any officer or employee of FDA or by any other officer or employee
acting on behalf of the Secretary of HHS. Section 801.410(f) requires that the results of impact
tests and description of the test method and apparatus be retained for a period of 3 years.
Specific recordkeeping requirements applicable to hearing aid dispensers, manufacturers of
menstrual tampons, and manufacturers of latex condoms are set forth in 21 CFR 801.421(d),
801.430(f), and 801.435(g), respectively.
Table 3.--Estimated Annual Third-Party Disclosure Burden1,2
No. of
No. of
Total
Average
Total
Respondents
Disclosures
Annual
Burden per
Hours
per
Disclosures
Disclosure
Respondent
Parts 800; and Part 801, subparts A, C, D, and E: General Labeling Provisions; OTC Devices; Exemptions
Contact lens cleaning solution
47
8
376
1
376
labeling; 800.10(a)(3) and
800.12(c)
Liquid ophthalmic preparation
25
8
200
1
200
labeling; 800.10(b)(2)
Manufacturer, packer, or
19,407
7
135,849
1
135,849
distributor information; 801.1
Adequate directions for use;
8,526
6
51,156
22.35
1,143,337
801.5
Statement of identity; 801.61
8,526
6
51,156
1
51,156
Declaration of net quantity of
8,526
6
51,156
1
51,156
contents; 801.62
Prescription device labeling;
9,681
6
58,086
17.77
1,032,188
801.109
Retail exemption for
30,000
667
20,010,000
0.25
5,002,500
prescription devices; 801.110
21 CFR Citation

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Processing, labeling, or
453
34
15,402
4
61,608
repacking; non-sterile devices;
801.150(e)
Part 801, subpart H: Special Requirements for Specific Devices
Labeling of articles intended
35
1
35
4
140
for lay use in the repairing
and/or refitting of dentures;
801.405(b)(1)
Dentures; information
35
1
35
4
140
regarding temporary and
emergency use; 801.405(c)
Hearing aids professional and
136
12
1,632
80
130,560
patient labeling; 801.420
Hearing aids, availability of
10,000
5
50,000
0.17
8,500
User Instructional Brochure;
801.421
User labeling for menstrual
16
8
128
2
256
tampons; 801.430
User labeling for latex
52
6
312
100
31,200
condoms; 801.437
Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
Format and content of labeling
1,700
6
10,200
80
816,000
for IVDs; 809.10
Advertising and promotional
300
25
7,500
1
7,500
materials for ASRs; 809.30(d)
Labeling of sunlamp products-30
1
30
10
300
1040.20(d)
FD&C Action Section 502(u)
Establishments listing < 10
161
2
322
0.1 (6
32
SUDs
minutes)
Establishments listing > 10
14
45
630
0.1 (6
63
SUDs
minutes)
Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent;
Reagent Red Blood Cells; Hepatitis B Surface Antigen; Anti-Human Globulin; Part 801 subpart A: General
Labeling Provisions; Part 809, subpart B: Labeling
Symbols glossary - 660.2;
antibody to Hepatitis B surface
antigen requirements, 660.28;
blood grouping labeling,
660.35; reagent red blood cell
labeling, 660.45, hepatitis B
3,000
1
3,000
4
12,000
surface antigen labeling,
660.55; anti-human globulin
labeling, 801.15; medical
devices labeling and use of
symbols; 809.10, labeling for
in vitro diagnostic products
Total
20,447,205
8,485,061

There are no capital costs or operating and maintenance costs associated with this collection of
information.
2
Numbers have been rounded.

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Because many labeling provisions correspond to specific recordkeeping requirements, we have
accounted for burden attendant to the provisions enumerated in table 3 as third-party disclosures.
These figures reflect what we believe to be the average burden incurred by respondents to
applicable information collection activities.
12b. Annualized Cost Burden Estimate
We updated the annual cost burden estimate based on the wage rate for a lawyer* ($122),
multiplied by the total estimated burden hours (12,303,422).
Type of
Respondent
Attorney

Total Burden
Hours
12,303,422

Hourly Wage Rate
$122

Total Respondent
Costs
$1,501,017,484

* The estimated wage rate for a lawyer is based on the Bureau of Labor Statistics (BLS)
hourly wage rate of $61 (https://www.bls.gov/ooh/legal/lawyers.htm, date accessed
September 10, 2021). The hourly wage rate of $122 assumes a 40-hour work week and is
rounded to the nearest dollar and has been doubled to account for benefits and overhead.
13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There is no capital, start-up, operating or maintenance cost associated with this information
collection.
14. Annualized Cost to the Federal Government
Review of labeling occurs generally as part of a premarket notification submissions or premarket
approval applications approved under OMB Control Nos. 0910-0120 and 0910-0231. Here we
estimate labeling reviews associated with specific requirements. Based on internal data,
approximately 10 FTEs are allocated for labeling reviews. Based on FDA/CDRH’s cost of
$263,326* annually, (which consists of the employee’s salary and any overhead which
accompanies that employee*), the total estimated annual Federal cost is $2,633,260.
*Based on the FY 2020 FDA Budget Request – Executive Summary – All Table

15. Explanation for Program Changes or Adjustments
This information collection reflects changes and adjustments. For efficiency of operations, we
have consolidated related information collections currently approved under OMB control
numbers 0910-0577 and 0910-0740. This results in an increase to the information collection of
15,095 burden hours annually. The increase is due to adjustments reflecting updated data and the
inclusion of the consolidated information collection. At the same time, we have reduced our

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estimate of disclosure responses by 1,597,520 annually. Upon review, we believe we previously
double-counted burden ascribed to disclosures provisions having accounted for the same burden
as that associated with recordkeeping activities.
Finally, upon submission of the ICR, we are correcting inadvertent calculation errors to the
burden hour increase and responses decrease displayed in our 60-day notice. Specifically,
additional burden hours have been added to the third-party disclosure burden table to reflect an
increase of 12,000 burden hours resulting in a total of 8,485,061 total burden hours for the thirdparty disclosure burden table. Also, additional responses have been added resulting in a total
increase in responses of 21,647,170.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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