# 2025-20772: FDA's Device Review Paper Trail Heads to OMB

2025-20772, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective Submit written comments (including recommendations) on the collection of information by December 24, 2025. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20772
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20772
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52971
- Published: 2025-11-24
- Effective: Submit written comments (including recommendations) on the collection of information by December 24, 2025.
- Comments close: 2025-12-24
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA's Device Review Paper Trail Heads to OMB

## Summary

The FDA is asking for public feedback on extending its 510(k) Third-Party Review Program, which lets private experts help review certain medical device applications. This program affects device makers who want faster reviews and keeps paperwork manageable. Comments are due by December 24, 2025, and the program helps speed up device approvals without extra costs to manufacturers.

## Abstract

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.

## Effects PRIA read

- Voluntary Third‑Party 510(k) Reviews: benefit, medium. You can choose to use accredited third‑party reviewers to have certain 510(k) premarket notifications reviewed. Participation is voluntary; accredited reviewers will review a manufacturer's 510(k) and forward the submission plus their documented review and recommendation to FDA, providing an altern…
- Time Burdens for 3PROs and Accreditation: cost, medium. If you are a third‑party review organization, FDA estimates an initial accreditation request takes 40 hours (updated from 24 hours, an increase of 15 hours), re‑recognition requests 24 hours, and each 510(k) review by a 3PRO averages 40 hours. FDA estimates total annual reporting burden of 5,152.25…
- Eligibility Limits: Class I and II Device Types: benefit, medium. Under section 523 of the FD&C Act and FDA guidance, FDA will identify which class I or class II device types, or subsets of those types, are eligible for review by an accredited person. The guidance describes the factors FDA will use to determine eligibility for third‑party 510(k) review.

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## Sources
- [2025-20772 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20772/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2025-20772 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20772.pdf)

## Related
- [Previous: 2025-20771, Agency Information Collection Activities; Submission for Office of Management a…](https://policyrisk.com/federal-register/2025-20771)
- [Next: 2025-20773, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2025-20773)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20772 (as of 2026-06-08).