The FDA may require a post-approval study (or studies) at the time of approval of a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) application to help ensure 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 or HDE approval order.)
The FDA's Post-Approval Studies Program ensures that sponsors use valid scientific methodologies in the study design, and post-approval studies are 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 Premarket Approval Order
- 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 information (for example: study description and interim or final study results) regarding each post-approval study ordered as condition of approval.
The database also provides the overall study status (based on timelines set in approval orders, the protocol and the adequacy of the data) and the applicant’s current reporting status for each submission due.
Note: A device may have more than one requirement imposed by an approval order.
Searching and Sorting the Database
Search: You can search the database for all orders by applicant, device name, or application number. To search the database, type the search term in the search field and click Search.
Sort or Filter: You can sort the database by applicant, device name, application number, medical specialty, or date of application approval.
- 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 Premarket Approval Order.
- Study Status in the database may include terms not specified in the guidance (“Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order”) as the terms in the guidance apply to new submissions or new studies received after publication of the final guidance. For an interim period, the status of some studies may be marked as Progress Adequate, Progress Inadequate, Other, or Revised/Replaced, reflecting prior policy, until new information is submitted to the FDA for review and the study status category is changed.
- 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 new post-approval study requirements, new or revised study information (such as protocol parameters, study status, or interim or final data summary), study enrollment status or reporting status.
Obtaining PMA Approval Letters, PAS Protocols, or PAS Final Reports
The Post-Approval Studies Database provides the link to the PMA approval information for devices with post-approval requirements. Selecting the link for the Application Number will go to PMA approval information in 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