FDA finalizes updates to the Special 510(k) program

October 1, 2019By: Adrienne R. Lenz

On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”). This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm — Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

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