The purpose of this web site is to ensure that stakeholders have access to current information about PAS, which may be required by the Center for Devices and Radiological Health to help assure continued safety and effectiveness of approved devices (see 21 CFR 814.82(a)(2)).
2. What information does the Post-Approval Study Status Web site include?
The site includes the status of post-approval studies CDRH imposed by Pre Market Approval (PMA) order since January 1, 2005.
The information included on this site is based on FDA's PAS tracking system.
3. What are the definitions for the post-approval terms used on this site?
Post-approval study is a clinical study or other investigation required in the PMA approval order to gather specific information to address precise study objectives about an approved medical device.
Post-approval study commitment is an agreement by the sponsor, and confirmed by FDA in writing, to conduct one or more post-approval studies. Completion of these studies will fulfill that post-approval study commitment.
Interim post-approval study status report is a written report to CDRH on the status of the post-approval study prior to its completion. Unless otherwise specified in the PMA approval order, the Interim Post-Approval Study Status Report will usually be submitted every 6 months for the first 2 years of the study and annually thereafter until the time the Final Post-Approval Study Report has been submitted.
Final post-approval study report is a written report based on the terminated study or the final results of the agreed upon and completed post-approval study. The Final Post-Approval Study Report should be submitted no later than three (3) months after study completion.
PAS Approval letter – This is a letter that informs the sponsor that the protocol or protocol revisions are approved.
PAS Approvable letter – This is a letter that informs the sponsor that their post-approval study protocol can be approved if they submit additional information regarding issues, concerns or submit additional information needed to complete the review of the submission.
PAS Accepted letter – This is a letter that informs the sponsor that their report has been accepted.
4. What are the sources of information for this site?
Information about post-approval studies comes from Agency letters and from interim PAS status reports submitted by the applicants. Information will be checked by the PAS Project Manager for accuracy before it is posted on the Web site.
5. How often will the Web site be updated?
We intend to update the website on the 5th of every month.
6. Can a device have more than one PAS related to it?
Yes, there can be more than one PAS related to the approval of a premarket approval application for a medical device, as well as more than one PAS.
7. When and how often must an applicant submit a post-approval study report to FDA?
Unless otherwise specified in the PMA approval order, you should submit an Interim Post-Approval Study Status Report every 6 months for the first 2 years and annually thereafter from the date of the PMA approval letter or other negotiated starting dates. This should continue until you have submitted the Final Post-Approval Study Report and we have notified you that you have met the commitment. For more information, you should refer to the CDRH guidance, “Procedures for Handling Post-Approval Studies Imposed by PMA Order.”
8. How soon will information from the latest post-approval report appear on the Web site?
FDA will try to post updates on the 5th of the month following submission. Delays may occur, depending on when the report is submitted and entered into the database. The current information included on this site is based on the FDA's post-approval study commitments database as of January 1, 2005, and will change as data are updated monthly.
9. How can I search the Post-Approval Study web page?
You can search by:
10. What will I see in my search results?
You will see the following information:
11. How can I obtain a copy of the PMA approval letter that ordered the post-approval study?
The PMA Approval letters as well as the Summary of Safety and Effectiveness Data are posted on the Office of Device Evaluation’s public website.
12. What do the "Study Progress" categories mean?
Study Status: You will see one of the terms below to describe the progress of the protocol or study
Protocol Pending: FDA has not approved the study protocol.
Study Pending: The protocol has been approved but the study has not begun (i.e., no subjects have been enrolled), and the projected date for completing patient accrual has not passed.
Study On-time: The study is proceeding according to, or is ahead of, the agreed upon schedule.
Study Overdue: The study has not been initiated by the projected date for completion of patient enrollment or the study is behind the agreed upon schedule.
Study Terminated: FDA granted an early termination of the study because the study is either no longer feasible or would no longer provide useful information.
Study Completed: FDA has reviewed the Final Post-Approval Study Report and determined that the study fulfills the commitment
13. How can I obtain a copy of a post approval-study 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.
14. Whom can I contact if I have additional questions?
If you have any questions or comments related to post-approval studies or this Web site, please send them to the Post-Approval Study Project Manager at nicole.jones@fda.hhs.gov.
Updated March 26, 2007
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
