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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 P100009
Current Protocol Accepted 04/05/2016
Study Name OSB Lead-New EnrollMitraClip Analysis Cohort (MAC)
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective cohort study, a subset of patients entered into the MitraClip TVT-Registry who fulfill   show the rest ...
Study Population Description A subset of approximately 460 patients entered into the MitraClip TVT-Registry who fulfill the following   show the rest ...
Sample Size Assuming 10% withdrawal at 12 months, a sample size of 460

patients from the Prohibitive Risk   show the rest ...
Data Collection Main safety endpoints:

A composite of death and device-related complications at 30 days

post-procedure. The device-related complications   show the rest ...
Followup Visits and Length of Followup 5 years

Active follow-up of patients will be performed through 12 months

OSB Lead-New EnrollMitraClip Analysis Cohort (MAC) Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report and 12 month report 07/28/2014 01/16/2015 Overdue/Received
18 month report 04/24/2015 04/30/2015 Overdue/Received
two year report 10/24/2015 10/22/2015 On Time
30 month report 04/24/2016 04/21/2016 On Time
three year report 10/24/2016    
Final Report 07/31/2017    

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