 
Today, the U.S. Food and Drug Administration (FDA) issued two final guidances that 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
This guidance 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.
This guidance will replace Procedures for Handling Post-Approval Studies Imposed by PMA Order, issued on June 15, 2009.
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
This guidance includes:
- An overview of section 522 of the FD&C Act.
- Information on how to fulfill section 522 obligations, including:
- when postmarket surveillance should start;
- recommendations for achieving an approved postmarket surveillance plan in a timely manner; and
- recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance;
- Recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions.
- Updated surveillance status categories to better reflect progress.
This guidance will replace Postmarket Surveillance Under Section 522 of the FD&C Act, issued on May 16, 2016.
Questions?
If you have questions about these final guidances, please contact the Office of Product Evaluation and Quality/Office of Clinical Evidence and Analysis/Division of Clinical Policy and Quality (OCEA) at MandatedStudiesPrograms@fda.hhs.gov
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