FDA Invites Comments on Third-Party Medical Device Review Data Practices
Published Date: 7/3/2025
Notice
Summary
The FDA wants your thoughts on how it collects info for the 510(k) Third-Party Review Program, which helps speed up medical device approvals. This affects companies making medical devices who use third-party reviewers. They’re asking for comments within 60 days, aiming to keep the process smooth without extra costs or delays.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
510(k) Third-Party Review Info Collection
If you make medical devices and use third-party reviewers, the FDA is asking for public comments for 60 days on the information it collects for the 510(k) Third-Party Review Program. The agency says this effort is meant to keep the review process running smoothly and avoid adding extra costs or delays for device makers.
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