FDA's Device Review Paper Trail Heads to OMB
Published Date: 11/24/2025
Notice
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.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Voluntary Third‑Party 510(k) Reviews
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 alternative review path intended to let FDA focus on higher‑risk devices and help speed device review for eligible manufacturers.
Time Burdens for 3PROs and Accreditation
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 hours and total annual recordkeeping burden of 1,287 hours; reviewers should usually keep 510(k) review records for 3 years.
Eligibility Limits: Class I and II Device Types
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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