Fact Sheet
Draft Guidance for Industry and Food and Drug Administration Staff – Deciding When to Submit a 510(k) for a Software Change to an Existing Device
Document issued on August 8, 2016 On August 8, 2016 the FDA released a draft guidance providing recommendations for manufacturers on when to submit a new premarket notification (510(k)) due to a software (including firmware) change to a 510(k)-cleared or pre-amendment device….
