Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-1210]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments (including recommendations) on the collection of information by January 21, 2026.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to

https://www.reginfo.gov/public/do/PRAMain

. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0449. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Amber Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,

PRAStaff@fda.hhs.gov

.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Postmarket Surveillance of Medical Devices—21 CFR Part 822

OMB Control Number 0910-0449—Extension

This information collection supports FDA regulations. Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers, so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with 21 CFR 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with 21 CFR 822.38. To assist respondents with understanding the applicable statutory and regulatory requirements, we also developed the interpretive agency guidance entitled, “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” (October 2022) (available at

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-surveillance-under-section-522-federal-food-drug-and-cosmetic-act

). Respondents to this collection of information are those manufacturers that require PS of their products.

In the

Federal Register

of June 6, 2025 (90 FR 25318) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden

1

21 CFR part/activity

Number of

respondents

Number of

responses per

respondent

Total annual responses

Average

burden per

response

Total hours

§§  822.9 and 822.10; PS submission

3

1

3

120

360

§  822.21; Changes to PS plan after approval

8

1

8

40

320

§  822.28; Changes to PS plan for a device that is no longer marketed

1

1

1

8

8

§  822.29; Waiver

1

1

1

40

40

§  822.30; Exemption request

1

1

1

40

40

§  822.38; Periodic reports

35

3

105

40

4,200

Total

4,968

1

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

Table 2—Estimated Annual Recordkeeping Burden

1

21 CFR part/activity

Number of

recordkeepers

Number of

records per

recordkeeper

Total annual records

Average

burden per

recordkeeping

Total hours

§  822.31; Manufacturer records

3

1

3

20

60

§  822.32; Investigator records

9

1

9

5

45

Total

105

1

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

Our estimated burden for the information collection reflects an increase of 1,890 total burden hours and a corresponding increase 45 total annual responses. This increase is based on internal FDA tracking data. The number of respondents varies annually, subject to the number of original plans, plan changes, and interim and final reports (which are dependent on enrollment progress for each study) received by FDA.

Brian Fahey,

Associate Commissioner for Legislation.

[FR Doc. 2025-23630 Filed 12-22-25; 8:45 am]

BILLING CODE 4164-01-P