0910-0625_Supporting Statement A_2025

Medical Device Registration and Listing

OMB Control No. 0910-0625 – EXTENSION

SUPPORTING STATEMENT

Part A: Justification:

1. Circumstances Making the Collection of Information Necessary

This information collection implements Food and Drug Administration (FDA, us or we) statutes and regulations governing medical device registration and listing. Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) governs registration of producers of devices, with implementing regulations at 21 CFR part 807. Domestic and foreign device establishments are required to submit registration and device listing information to FDA by electronic means rather than on paper forms, and in accordance with established submission schedules. Regulations in 21 CFR part 807, subparts A through D, identify who must register. The regulations also set forth format and content requirements and provide for a timed submission schedule, included the submission of updated information. To assist respondents with the information collection we maintain a website at https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing, including a comment field. We utilize Form FDA 3673, which is electronically formatted for web submission, to provide a uniform format for submission of required information.

We therefore request extension of OMB approval for information collection found in 21 CFR part 807, subparts A through D, and electronic Form FDA 3673, as discussed in this supporting statement.

2. Purpose and Use of the Information Collection

We use the information collection to identify: (1) Firms subject to FDA's regulations, (2) geographic distribution in order to effectively allocate FDA's field resources for inspections, and (3) the class of the device that determines the frequency of inspection. As a result, when complications occur with a particular device, all manufacturers of similar or related devices can be more readily identified. The information collection is also intended to mitigate bioterrorism threats and other public health emergencies.

The respondents to this information collection are private sector (both for profit and not for profit) owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements.

3. Use of Improved Information Technology and Burden Reduction

The information collection is administered electronically using the FDA Unified Registration and Listing System (FURLS) to facilitate the electronic submittal of registration and listing information and to provide faster access to this information for both industry and FDA. This technology allows FDA to more effectively gather establishment registration information to help identify firms and the locations involved with the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices. We estimate 99% of respondents submit information electronically, reserving 1% for those requesting waiver from the electronic requirements.

Our Center for Devices and Radiological Health (CDRH) has developed step-by-step instructions explaining how firms submit registration and listing information electronically in FURLS to comply with the registration and listing requirements initially and annually. These step-by-step instructions can be found online at https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list#13.

4. Efforts to Identify Duplication and Use of Similar Information

We are unaware of duplicative information collection. Information collection pertaining to the premarket notification of medical devices is governed by regulations in 21 CFR part 807, subpart E, and approved under OMB control no. 0910-0120.

5. Impact on Small Businesses or Other Small Entities

The information collection does not impose undue burden on small entities. The regulations provide for a waiver from submitting registration and listing information electronically. As instructed on our website, waiver requests should be submitted to the following address:

Food and Drug Administration

CDRH - Office of Regulatory Programs

Imports and Registration & Listing

10903 New Hampshire Avenue

Building 66 Room 1431

Silver Spring, MD 20993-0002

At the same time, FDA aids small business by providing guidance and information through our Center for Devices and Radiological Health (CDRH), Division of Industry and Consumer Education (DICE). DICE provides workshops and other technical and non-financial assistance to small manufacturers. The workshops make available publications and educational materials, which include medical device establishment and listing requirements. The Division also maintains a toll-free “800” telephone number which firms may use to obtain regulatory compliance information. These efforts help to assure that the burden on small manufacturers is minimized.

6. Consequences of Collecting the Information Less Frequently

Failure to collect the required information as prescribed by statute would violate FDA’s mandate under Section 510 of the FD&C Act.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances associated with the information collection.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

In the Federal Register of June 20, 2025 (90 FR 26304), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

9. Explanation of Any Payment or Gift to Respondents

There are no incentives, payments or gifts associated with this information collection.

10. Assurance of Confidentiality Provided to Respondents

The Privacy Act of 1974

In preparing this supporting statement, we consulted with our Privacy Office to ensure appropriate handling of information collected. Although this ICR collects personally identifiable information (PII), it is collected in the context of the subject individuals’ professional capacity and the FDA-related work they perform for their employer (e.g. point of contact of a regulated entity). The PII collected is name, work address, work email address, work telephone number and occasionally work fax number. We have determined, however, 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, the contractor or FDA does not use name or any other personal identifier to retrieve records from the information collected. Through appropriate design, FDA limited submission fields and minimized the PII collected to protect the privacy of the individuals.

The Freedom of Information Act (FOIA)

Under the 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 (see 21 CFR 20), consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information.

11. Justification for Sensitive Questions

The collection of information does not involve sensitive questions.

12. Estimates of Annualized Burden Hours and Cost

12a. Annualized Hour Burden Estimate

Table 1.--Estimated Annual Reporting Burden
21 CFR Part FDA Form Number	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response	Total Hours
807.20(a)(5)2 Initial Submittal of Manufacturer Information by Initial Importers (FDA 3673)	2,219	1	2,219	1.75	3883
807.20(a)(5)3 Annual Submittal of Manufacturer Information by Initial Importers (FDA 3673)	2,219	1	2,219	0.1	222
807.21(a)2 Creation of electronic system account (FDA 3673)	8,876	1	8,876	0.5	4,438
807.21(b)3 Annual Request for Waiver from Electronic Registration & Listing	1	1	1	1	1
807.21(b)2 Initial Request for Waiver from Electronic Registration & Listing	1	1	1	1	1
807.22(a)2 Initial Registration & Listing (FDA 3673)	2,106	1	2,106	1	2,106
807.22(b)(1)3  Annual Registration (FDA 3673)	30,280	1	30,280	0.5	15,140
807.22(b)(2)3 Other updates of Registration (FDA 3673)	3,906	1	3,906	0.5	1,953
807.22(b)(3)3  Annual Update of Listing Information (FDA 3673)	28,925	1	28,925	0.5	14,463
807.22(b)(4) Changes to listing information (outside of annual listing requirement period)
Voluntary reporting of transfer of 510(k) clearance in FURLS (outside of annual listing requirement period)	4,080	1	4,080	0.25	1,020
Submission of 510(k) transfer documentation when more than one party lists the same 510(k)	2,033	1	2,033	4	8,132
807.26(e)3 Labeling & Advertisement Submitted at FDA Request	1	1	1	1	1
807.34(a)2 Initial Registration & Listing when Electronic Filing Waiver Granted	1	1	1	1	1
807.34(a)3 Annual Registration & Listing when Electronic Filing Waiver granted	1	1	1	1	1
807.40(b)(2)3  Annual Update of US Agent Information (FDA 3673)	3,410	1	3,410	0.5	1,705
807.40(b)(3)3 US Agent Responses to FDA Requests for Information (FDA 3673)	1,535	1	1,535	0.25	384
807.41(a)3 Identification of initial importers defined in 21 CFR 807.3(g) by foreign establishments (FDA 3673)	2,955	1	2,955	0.5	1,478
807.41(b)3 Identification of other importers (defined in 21 CFR 807.3(x) and (y) that facilitate import by foreign establishments (FDA 3673)	3,234	1	3,234	0.5	1,617
Total					56,546

¹Totals are rounded to the nearest whole number.

²One Time Burden – Firm only provides initially.

³Recurring Burden – Firm is required to review annually.

Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Part	No. of Recordkeepers	No. of Records per Recordkeeper	Total Annual Records	Average Burden per Recordkeeping	Total Hours
807.25(d)2 List of Officers, Directors & Partners	22,338	1	22,338	.25	5,585
807.262 Labeling & Advertisements Available for Review	17,032	4	68,128	.5	34,064
Total					39,649
1There are no capital costs or operating and maintenance costs associated with this collection of information. 2Recurring burden – Firm is required to keep records.

The estimates for creation of new user accounts under § 807.21(a) are based on the number of newly registered owners and operators. An owner or operator only creates an account one time when they register for the first time (initial registration). Once the account is created, the owner or operator uses the account as long as the establishment is registered. If an owner or operator changes, the new owner or operator creates a new owner or operator account and transfers the ownership of the establishment to their owner or operator account. Once they create an owner or operator account, they use the account for as long as the company is registered.

Under § 807.22(b)(4), changes to listing information may be made at times outside of the annual listing requirement period, such as when a change is made to a previously listed device.

Our medical device registration and listing website (https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing) communicates instructions explaining how a firm performs a transfer of ownership of Devices and Facilities in FURLS. To notify FDA of the transfer of a premarket notification (510(k)) clearance from one person to another, the new owner must create a new listing for the 510(k) while the previous owner must deactivate their listing for the 510(k). Owners are responsible for ensuring public information in FDA’s databases about the current 510(k) holder for a specific device(s) is accurate and up to date. We estimate it will take respondents approximately 4 hours to establish information regarding the transfer of a 510(k) clearance.

We estimate that annually 78 percent of 510(k)s may be initially listed or updated outside of the annual registration requirement (about 4,080 510(k)s per year). We estimate that it will take approximately 15 minutes for each listing, for a total reporting burden of 1,020 hours.

We estimate 2,033 instances of more than one party claiming to be a 510(k) holder for a specific device as part of annual registration and listing. We base this estimate on the average number of unique 510(k) device listings entered in FURLS during fiscal year 2024 that conflict with a listing already entered by another party (5,304), dividing that number by the number of years (3) and multiplying by the average number of parties claiming to be the 510(k) holder when there is a conflict in the current FURLS database (2.3), then dividing the result by 2 (because only one company per listing will submit the appropriate documentation to show that they are the current 510(k) holder).

The recurring burden for the data collection under § 807.41 (import-related information provided by foreign companies exporting to the United States) was estimated based on data from previous years. Foreign companies identify one importer and one person who imports or offers for import with readily available contact information at the time of registration. After completing their initial registration, they are required to review the importer information annually. Upon review, they simply verify the importer information is accurate. If it is and no changes are needed, the foreign establishment’s official correspondent checks the certification and submits the annual registration. If they need to make changes to the importer information, they can do so at any time and use a spreadsheet to update more than one importer at a time to their registration. The use of the spreadsheet reduces the burden to the official correspondent of the foreign establishment.

The estimate for § 807.25(d) in table 2 of this document (recordkeeping burden) reflects the requirement that owners or operators keep a list of officers, directors, and partners for each establishment. Owners or operators will need to provide this information only when requested by FDA. However, it is assumed that some effort will need to be expended to keep such lists current.

The burden estimate does not include the maintenance of records used to document transferring a premarket notification (510(k)) clearance. Based on available information, FDA believes that the maintenance of these records is a usual and customary part of normal business activities. For example, in the ordinary course of business, supporting documents should be kept for tax purposes.

12b. Annualized Cost Burden Estimate

We assume the activities identified in 12a will be completed by regulatory affairs professionals. To estimate costs to respondents, we used mean wage rates from the U.S. Department of Labor’s Bureau of Labor Statistics National Occupational Employment and Wage Estimates (available at http://www.bls.gov/oes/current/oes_nat.htm) (May 2023) for Lawyers (occupation code 23-1011) (approximately 50% of tasks) and Paralegals (occupation code 23-2011) (approximately 50% of tasks). We doubled these figures to account for benefits and overhead, and calculated the costs as follows:

Table 3. – Annualized Burden Costs1
Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Lawyer	48,098	170	8,176,660
Paralegal	48,098	64	3,078,272
Total			11,254,932

¹ Figures rounded to the nearest whole dollar.

We therefore estimate a total annualized cost burden of $11,254,932 (rounded).

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs

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

14. Annualized Cost to the Federal Government

We estimate an average allocation of two full time equivalent (FTE) FDA employees for the administration of the information collection. Assuming a cost of $362,271.92 per position (which is the FDA CDRH projected average cost of an FTE including non-pay costs*), we estimate an annual cost to the Federal government of $724,544 ($362,272 x 2 FTEs).

*Based on the Food and Drug Administration fully loaded FTE cost model (domestic) for FY 2024 as provided by agency economists.

15. Explanation for Program Changes or Adjustments

Our estimated burden for the information collection reflects an overall decrease of 17,637 hours and a corresponding decrease of 34,526 responses/records. We attribute this adjustment to a decrease in the number of submissions we received over the last approval period.

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 and inform respondents of its significance in accordance with PRA requirements.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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