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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 P020018 S040
Current Protocol Accepted 04/02/2014
Study Name OSB Lead-Training Program
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multicenter single-arm registry study
Study Population Description Patients undergoing treatment for AAA with the Zenith fenestrated AAA endovascular graft who completed training   show the rest ...
Sample Size 82 subjects; no controls
Data Collection Technical success of implant
Followup Visits and Length of Followup None


Final Study Results
Actual Number of Patients Enrolled 82
Actual Number of Sites Enrolled 47
Patient Followup Rate 100%
Final Safety Findings No safety endpoints in this study
Final Effectiveness Findings Technical success rate if implantation = 91.5%
Study Strengths and Weaknesses There was 100% follow쳌]up of study subjects, and endpoint was fully assessed in all subjects.   show the rest ...
Recommendations for Labeling Changes No labeling change is recommended because there is no new information that is thought to   show the rest ...

OSB Lead-Training Program Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/03/2012 11/09/2012 Overdue/Received
one year report 04/04/2013 04/04/2013 On Time
18 month report 10/03/2013 10/04/2013 Overdue/Received
two year report 04/04/2014 04/02/2014 On Time
Final Report 07/03/2014 07/03/2014 On Time

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