Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order

7 October 2022 — FDA published the final PAS guidance for industry and FDA staff.

A PAS is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the post market performance of or experience with an approved medical device. The purpose of this guidance document is to assist stakeholders with understanding postapproval study (PAS) requirements imposed as a condition of PMA approval.