The FDA may require a post-approval study (or studies) at the time of approval of a Premarket Approval (PMA), Humanitarian Device Exemption (HDE), or product development protocol (PDP) application to help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device.
Post-approval studies are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for the FDA to withdraw approval. (Note: A device may have more than one post-approval study imposed by a PMA, HDE, or PDP application.)
The FDA's Post-Approval Studies Program ensures that methodologies are well-designed and conducted effectively, efficiently and in the least burdensome manner.
On This Page:
- Post-Approval Studies (PAS) Database
- Obtaining PMA Approval Letters, PAS Protocols, or PAS Final Reports
- Contact Information
- Guidance Document: Procedures for Handling Post-Approval Studies Imposed by PMA Order - June 15, 2009
- September 2015 GAO Report: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing (PDF-845KB)
Post-Approval Studies Database
CDRH established the Post-Approval Studies Database to share general information regarding each post-approval study ordered as condition of approval.
The database provides the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s current reporting status for each submission due.
Searching and Sorting the Database
Search: You can search the database for all orders by manufacturer, device name, medical specialty, or application number. To search the database, type the search term in the search field and click Search.
Sort: You can sort the database by manufacturer, device name, application number, or date.
- Click the button for the type of orders you want to sort: Active, Inactive, or All Orders.
- Click the arrow in the column heading to sort the displayed orders.
Terms Used in the Database
For definitions of terms used in the database, refer to the guidance, Procedures for Handling Post-Approval Studies Imposed by PMA Order.
- Study Status in the database is listed as Study Status Determination in the guidance.
- Applicant’s Reporting Status in the database is listed as Sponsor’s Reporting Status in the guidance.
Updates to Study Information in the Database
The FDA updates the database every Sunday with any new or revised information on study protocol parameters (for example, patient population), overall study status, or information related to the review of data from interim or final reports.
Obtaining PMA Approval Letters, PAS Protocols, or PAS Final Reports
The Premarket Approval (PMA) for a device includes the order for post-approval studies, as well as the Summary of Safety and Effectiveness Data (SSED). To access the approval letter, go to the Premarket Approval (PMA) database.
To obtain a PAS protocol or final study report, you may:
- Submit the request directly to the manufacturer.
- Submit a FOIA request to the FDA. For more information, see Freedom of Information Act: How to Make a FOIA Request.
Mandated Studies Program
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: [email protected]