![]() The program is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher risk devices, while still maintaining oversight of the review of lower risk devices eligible for third party review. The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations (3P510k Review Organizations) are allowed to review certain low-to-moderate risk medical devices. 510(k) Third Party Performance Metrics and Accreditation Status.Resources for Third Party Review Organizations.Interacting Early with the FDA During a 510(k) Review.How to Become a Third Party Review Organization.How to Submit a 510(k) Through the Third Party Review Program.Update: August 19, 2022: If manufacturers are considering seeking 510(k) clearance for personal protective equipment, most masks (such as product code FXX) and gloves (such as product codes LYY, LYZ, LZA, KGO, and LZC) are eligible for 510(k) Third Party Review. ![]()
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