Post-Approval Studies (PAS) - Frequently Asked Questions (FAQ)
- When does FDA require a post-approval study (PAS)?
- Why is FDA providing the PAS webpage?
- How can I search the PAS webpage?
- Where can I get definitions for the terms used on the PAS webpage?
- How often will the PAS webpage be updated?
- Can a device have more than one PAS related to it?
- How can I obtain a copy of the PMA approval letter that ordered the post-approval study?
- How can I obtain a copy of a PAS protocol or final report?
- Whom can I contact if I have additional questions?
1. When does FDA require a post-approval study (PAS)?
FDA has the authority to require sponsors to perform 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.
2. Why is FDA providing the PAS webpage?
The purpose of this webpage is to ensure that stakeholders have access to current information about post-approval studies that were required by FDA. This webpage includes the status of post-approval studies imposed since January 1, 2005.
3. How can I search the PAS webpage?
You can find information by:
- selecting one of the alphabetical buttons at the top of the page to go directly to the applicant names that begin with that letter; or
- sorting the data in ascending or descending order by clicking one of the arrows in the column headers:
- Application Number
- Applicant Name
- Device Name
- Medical Specialty
- Date PMA Approved.
4. Where can I get definitions for the terms used on the PAS webpage?
Definitions for Study Status and Applicant’s Reporting Status are available in our PAS guidance document entitled, “Procedures for Handling Post-Approval Studies Imposed by PMA Order,” which is available on this webpage.
5. How often will the PAS webpage be updated?
We update the webpage based on any new or revised information on study protocol parameters (e.g., patient population) or the review of data from interim or final reports. While most data elements in the webpage table are not expected to change after the initial entry, overall study status and information related to the applicant’s reporting status are.
6. Can a device have more than one PAS related to it?
Yes, there can be more than one PAS imposed by a PMA, PDP, or HDE application.
7. How can I obtain a copy of the PMA approval letter that ordered the post-approval study?
The approval letters, as well as the Summary of Safety and Effectiveness Data (SSED), are posted on the Office of Device Evaluation’s public website.
8. How can I obtain a copy of a PAS protocol or final report?
Protocols and final study reports can be requested either directly from the applicant or from FDA under the Freedom of Information Act (5 U.S.C. 552) (FOIA). FDA will comply with the requirements of 21 CFR Part 20 on the disclosure of information.
9. Whom can I contact if I have additional questions?
If you have any questions or comments related to post-approval studies or this webpage, please send them to the Post-Approval Studies Project Manager at email@example.com or to the Associate Director, Program Operations firstname.lastname@example.org