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

Description

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.

Scope & Applicability

Regulatory Context

• 21CFR814.82§ 814.82 Postapproval requirements.

  (a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →

• 21CFR814.9§ 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.

  (a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under § 814.82 , any master file, or any other related submission. Any record in the PMA file will be available for public discRead full regulation →

• 21CFR814.39§ 814.39 PMA supplements.

  (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →

• 21CFR814.46§ 814.46 Withdrawal of approval of a PMA.

  (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that:Read full regulation →

• CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded

  Allergan

  2020-05-14

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