Post Market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

6 October 2022 — FDA published the final post market surveillance guidance for industry and FDA staff.

The purpose of this guidance document is to assist manufacturers of devices subject to section 522 post market surveillance orders (522 orders) by providing information on how to fulfill section 522 obligations.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /