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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 P070005
Current Protocol Accepted 03/06/2009
Study Name REPEL CV
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description This is a multi-center, comparative, randomized study of REPEL-CV in pediatric patients (<21 years of   show the rest ...
Study Population Description The population will be pediatric (<21 years of age) patients who are greater than 48   show the rest ...
Sample Size 640 patients randomized and treated with either REPEL-CV (320 patients) or the untreated study-directed control   show the rest ...
Data Collection The primary safety endpoint will be the incidence of a composite measure based on the   show the rest ...
Followup Visits and Length of Followup Patients will be followed for 6 months post initial sternotomy. However, patients who undergo a   show the rest ...

REPEL CV Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 02/08/2010 02/05/2010 On Time
1 Year report 03/06/2010 03/03/2010 On Time
18 month report 09/04/2010 12/10/2010 Overdue/Received
2 year report 03/06/2011 03/07/2011 Overdue/Received
30 month report 09/14/2011 09/14/2011 On Time
3 year report 03/06/2012 03/07/2012 Overdue/Received
42 month report 09/06/2012 09/05/2012 On Time
48 month report 03/16/2013 06/14/2013 Overdue/Received
54 month report 09/14/2013 09/10/2013 On Time

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