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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 P010012 S230
Current Protocol Accepted 01/18/2013
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
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 Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Patients in the NCDR ICD Registry will be identified, who, at the time of

device implant   show the rest ...
Sample Size A minimum of 1300 patients who meet the specified criteria; have

been implanted with a Boston   show the rest ...
Data Collection The primary endpoint for the study is to evaluate the ¿real-world¿ effect of

CRT-D, compared to   show the rest ...
Followup Visits and Length of Followup 5-years post-implant.

Progress reports will be generated every 12 months and will include:

demographics, mortality, and procedural   show the rest ...


Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 03/17/2011 03/16/2011 On Time
one year report 09/16/2011 09/14/2011 On Time
18 month report 03/16/2012 03/15/2012 On Time
two year report 09/15/2012 09/17/2012 Overdue/Received
three year report 01/31/2014 01/27/2014 On Time
four year report 01/31/2015 01/30/2015 On Time
five year report 01/31/2016 01/27/2016 On Time
six year report 01/31/2017    

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