Postmarket Surveillance

Six years after releasing draft guidance the FDA has released final guidance on device postmarket studies and postmarket surveillance.

The issued guidance, published on the 7th of October 2022, provides direction to manufacturers of Class II and Class III devices in the timely initiation and completion of studies in fulfilling post-market surveillance requirements and of Post Approval Studies (PAS).

Under the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA has the power to issue post-market surveillance orders at the approval stage or at any point after. These are known as a “522 order”.

FDA states that:

“The purpose of this guidance document is to assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing information on how to fulfill section 522 obligations. The final guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” is intended to update and replace the guidance issued in May 2016.”

The guidance can be found at : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-surveillance-under-section-522-federal-food-drug-and-cosmetic-act

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