FDA finalizes updates to the Special 510(k) programOctober 1, 2019
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.
- Adrienne R. Lenz
Principal Device Regulatory Expert