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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 P040021
Current Protocol Accepted 08/30/2012
Study Name OSB Lead-Biocor & Biocor Supra Valves
Study Status Completed
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 Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective cohort
Study Population Description Subjects requiring an aortic valve replacement were implanted with either the Biocor aortic valve or   show the rest ...
Sample Size A total of 800 patient- years of follow-up with a minimum of 100 patients followed   show the rest ...
Data Collection NYHA, hemolysis, nonstructural dysfunction, paravalvular leak, structural deterioration/failure, bleeding events, embolism, endocarditis, valve thrombosis, reoperation,   show the rest ...
Followup Visits and Length of Followup >120 patients would be out 4 years or more, -50-70 patients will be out 6   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 300 (297 subjects met eligibility criteria)
Actual Number of Sites Enrolled 17
Patient Followup Rate at 5 years (114 eligible subjects) - 94.7% (108/114)

Overall cumulative follow-up - 959.4 late patient-years   show the rest ...
Final Safety Findings Early adverse event rate (? 30 days post implant) based on 297 subjects:

Bleeds 7.4% (7.1%   show the rest ...
Final Effectiveness Findings The proportion of subjects in NYHA class I or II at 5 years: all Biocor   show the rest ...
Study Strengths and Weaknesses The study achieved a high follow-up rate of 94.7% at 5-year post implant, and an   show the rest ...
Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The   show the rest ...

OSB Lead-Biocor & Biocor Supra Valves Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 08/05/2006 09/11/2006 Overdue/Received
2 year report 08/05/2007 08/03/2007 On Time
3 year report 08/04/2008 08/04/2008 On Time
4 year report 08/04/2009 08/05/2009 Overdue/Received
5 year report 08/04/2010 07/29/2010 On Time
annual report 08/03/2011 08/03/2011 On Time
7 year report 08/03/2012 08/02/2012 On Time
8 year report 08/05/2013 07/29/2013 On Time
9 year report 08/05/2014 08/01/2014 On Time
10 year report 08/05/2015 08/05/2015 On Time
Final Report 12/01/2015 12/01/2015 On Time

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