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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 P110021
Current Protocol Accepted 10/19/2012
Study Name OSB Lead-Continue F/u of Premarket Cohort
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Final Study Results
Actual Number of Patients Enrolled 115
Actual Number of Sites Enrolled 25
Patient Followup Rate 94.8%
Final Safety Findings At 5 year follow-up, the rates for major adverse events (in descending order) are all-cause   show the rest ...
Final Effectiveness Findings At 5 year follow-up, the mean values ± standard deviation for quality of life measures   show the rest ...
Study Strengths and Weaknesses Strength: Longer-term (5-year) safety and effectiveness results are obtained and the device benefits over risks   show the rest ...
Recommendations for Labeling Changes Labeling update is not needed because Edwards Lifesciences LLC ceased US market distribution of the   show the rest ...

OSB Lead-Continue F/u of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 04/19/2013 04/19/2013 On Time
one year report 10/19/2013 10/16/2013 On Time
18 month report 05/09/2014 05/06/2014 On Time
two year report 10/19/2014 10/15/2014 On Time
final report 10/19/2015 04/03/2015 On Time

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