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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P100041
Current Protocol Accepted 08/28/2014
Study Name OSB Lead-Newly Enrolled Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Design: a non-randomized, retrospective, consecutively enrolled STS/ACC TVT Registry of all patients undergoing SAPIEN transcatheter   show the rest ...
Study Population Description Patients must meet the fundamental enrollment criteria of severe, symptomatic, calcific aortic stenosis with quantifiable   show the rest ...
Sample Size A total of 5000 subjects combined for P110021 & P100041 patients enrolled into the STS/ACC   show the rest ...
Data Collection Primary Safety Endpoints:

The primary safety endpoint is the clinical event of stroke at 30 days,   show the rest ...
Followup Visits and Length of Followup 5 years

OSB Lead-Newly Enrolled Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
one year report 04/06/2013 04/29/2013 Overdue/Received
18 month report 10/06/2013 10/08/2013 Overdue/Received
two year report 04/06/2014 04/17/2014 Overdue/Received
three year report 04/06/2015 04/06/2015 On Time
four year report 04/06/2016 04/06/2016 On Time
five year report 04/06/2017    

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