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Business · 01/08/2011Updated: 10/17/2026 · 1 min read

FDA Requests Comments on 35-Year Review of 510(k) Clearance Process

Summary

The FDA is seeking public input on a report from the Institute of Medicine that evaluates the effectiveness of the 510(k) clearance process, which has been in place for 35 years, and may lead to changes in the process in the future.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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