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Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices

Notice.

📖 Research Context From Federal Register API

Summary:

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for postmarket surveillance of medical devices.

Key Dates
Citation: 90 FR 25318
Either electronic or written comments on the collection of information must be submitted by August 15, 2025.
Comments closed: August 15, 2025
Public Participation

In Plain English

What is this Federal Register notice?

This is a notice published in the Federal Register by Health and Human Services Department, Food and Drug Administration. Notices communicate information, guidance, or policy interpretations but may not create new binding obligations.

Is this rule final?

This document is classified as a notice. It may or may not create enforceable regulatory obligations depending on its specific content.

Who does this apply to?

Notice.

When does it take effect?

Either electronic or written comments on the collection of information must be submitted by August 15, 2025.

Why it matters: This notice communicates agency policy or guidance regarding applicable regulations.

Document Details

Document Number2025-10885
FR Citation90 FR 25318
TypeNotice
PublishedJun 16, 2025
Effective Date-
RIN-
Docket IDDocket No. FDA-2025-N-1210
Pages25318–25319 (2 pages)
Text FetchedNo

Agencies & CFR References

CFR References:
None

Linked CFR Parts

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Paired Documents

TypeProposedFinalMethodConf
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Related Documents (by RIN/Docket)

Doc #TypeTitlePublished
2025-23630 Notice Agency Information Collection Activities... Dec 23, 2025

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