Day: September 19, 2019

Several revised or updates USFDA guidance

9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff 9/13/2019 – The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff 9/13/2019 – The Special 510(k) Program: Guidance for Industry and Food and Drug […]