FDA Fine-Tunes Appeals for Device Decision Disputes
Published Date: 11/28/2025
Notice
Summary
The FDA is updating how people can appeal decisions about medical devices and radiological health. This change affects companies and individuals who want to challenge FDA reviews, making the process clearer and easier to follow. Comments on these updates are open until December 29, 2025, with no new fees involved.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Easier CDRH Appeals Submission
If you are a company or individual appealing a Center for Devices and Radiological Health (CDRH) decision, FDA's March 2022 guidance gives recommended formats and content for appeal requests. The guidance (and a March 2020 companion Q&A) says following these recommendations will help the agency consider your request and may facilitate a more timely resolution.
Time Burden for Appeals Submissions
FDA estimates about 75 appeal submissions per year with an average of 8 hours to prepare each request, totaling 600 hours annually. The agency reports an overall increase of 320 hours and 40 responses compared with the prior approval cycle, and states there are no capital costs or operating and maintenance costs tied to this collection.
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Key Dates
Department and Agencies
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