FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

By MedTech Intelligence Staff
October 11, 2022


• Categories: 05-Quality/Regulatory, Quality Management, Regulatory

This month, the FDA issued two final guidances related to post-approval studies and postmarket surveillance of medical devices.

Per the FDA announcement, these guidances are “intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These guidances are also intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and PAS requirements.”

“Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order” includes:

• Procedural information
• Recommendations concerning the format, content and review of PAS-related submissions
• Recommendations to help facilitate the FDA’s review of a PAS protocol in a timely manner
• Recommendations for study timelines including enrollment milestones and study completion
• Revised definitions to PAS status categories that better reflect progress of the PAS
• Revised FDA review time goals for PAS-related submissions

The final guidance replaces the guidance issued in June 2009.

“Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” supersedes previous guidance issued on May 16, 2016, and pertains to manufacturers of certain class II or class III devices. The final guidance covers:

• Postmarket surveillance plans, including changes to an approved postmarket surveillance plan
• When and how to submit postmarket surveillance reports, including content and format of reports
• Evaluation of reports and possible FDA actions after completion
• Failure to comply
• Public disclosure of postmarket surveillance plans and reports.