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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P010031 S232
Current Protocol Accepted 06/29/2012
Study Name REVERSE NCDR ICD Registry Study
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 No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Patients meeting the expanded CRT-D indication criteria are eligible to participate the analysis cohort.   show the rest ...
Sample Size At least 1500 patients from US implanted with a Medtronic CRT-D device who meet the   show the rest ...
Data Collection 5-year survival probability for patients implanted with a Medtronic CRT-D who meet the expanded indication   show the rest ...
Followup Visits and Length of Followup 5-years post-implant.



Reconciliation of mortality for patients identified through the NCDR® ICD Registry¿ will be completed   show the rest ...


REVERSE NCDR ICD Registry Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 10/03/2012 10/03/2012 On Time
one year report 04/04/2013 03/29/2013 On Time
18 month report 10/03/2013 10/02/2013 On Time
two year report 04/04/2014 03/20/2014 On Time
three year report 04/04/2015    
four year report 04/03/2016    
five year report 04/03/2017    

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