Posted by Michael Wonder on 26 May 2021
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices.
The first guidance on post market surveillance guidance will assist manufacturers of devices subject to an order under section 522 of the Federal Food, Drug, and Cosmetic Act, which authorises the FDA to require post market surveillance (522 order) at any time in the lifecycle of certain Class II (moderate risk) and III (high risk) devices.
