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GUIDANCE DOCUMENT

Procedures for Handling Post-Approval Studies Imposed by PMA Order Guidance for Industry and Food and Drug Administration Staff October 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2005-D-0027
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2005-D-0027.

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