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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 P860057 S042
Current Protocol Accepted 11/03/2009
Study Name OSB Lead-Clinical 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 New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a single arm prospective multi-site study, to be conducted at up to 25   show the rest ...
Study Population Description Study Population: Patients eligible for mitral valve replacement. Indication: It is intended for patients who   show the rest ...
Sample Size 225 patiens at up to 20 sites
Data Collection Primary safety endpoints include thromboembolism, hemorrhage, perivascular leak, and endocarditis. Secondary safety endpoints include blood   show the rest ...
Followup Visits and Length of Followup Follow-up visits will occur postoperatively, at discharge, at 6 months, one year, and annually thereafter,   show the rest ...

OSB Lead-Clinical Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 08/05/2010 08/04/2010 On Time
1 year report 11/05/2010 11/02/2010 On Time
18 month report 05/07/2011 05/09/2011 Overdue/Received
2 year report 11/05/2011 11/04/2011 On Time
3 year report 08/04/2012 08/01/2012 On Time
4 year report 05/06/2013 06/25/2013 Overdue/Received
5 year report 05/06/2014 05/05/2014 On Time
6 year report 05/06/2015 04/30/2015 On Time
7 year report 05/05/2016 05/02/2016 On Time
8 year report 05/05/2017    
Final Report 08/04/2017    

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