Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff

Issue Date: October 7, 2022
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final

Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration 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 postmarket performance of or experience with an approved medical device. The purpose of this guidance document is to assist stakeholders with understanding post approval study (PAS) requirements imposed as a condition of PMA approval. The final guidance “Procedures for Handling Post-Approval Studies Imposed by PMA Order” is intended to update and replace the guidance issued in June 2009.

Download the Guidance Document