Guidance Refuse to Accept Policy for 510(k)s
Posts published in “Premarket Notification – 510(k)”
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
List of November 2018 510(k) clearances. With the recent suggestions by FDA management on future changes of the 510(k) process, keeping up-to-date with clearances (and potentially…