f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The 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. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 12/16/2006 12/15/2006 On Time
2 year report 12/16/2007 12/17/2007 Overdue/Received
3 year report 12/15/2008 12/17/2008 Overdue/Received
4 year report 12/15/2009 12/10/2009 On Time
5 year report 12/15/2010 12/15/2010 On Time
6 year report 12/15/2011 12/15/2011 On Time
7 year report 12/14/2012 12/10/2012 On Time
8 year report 12/14/2013 12/19/2013 Overdue/Received
9 year report 12/14/2014 12/12/2014 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources