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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 P100041
Most Recent Protocol Version Approved 01/31/2012
Study Name Continue Follow-Up of Premarket Cohort
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of Cohort B device patients from premarket study. Premarket study was a prospective,   show the rest ...
Study Population Description Cohort B ¿ Non-surgical patients undergoing transcatheter

aortic valve implantation (treatment) via transfemoral delivery vs. best   show the rest ...
Sample Size 350 patients in the best medical therapy cohort (Cohort B).

25 sites

Data Collection Cohort B: (1) Freedom from death, over the duration of the trial and (2) Composite   show the rest ...
Followup Visits and Length of Followup Minimum of 5 years


Continue Follow-Up of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 05/02/2012 08/01/2012 Overdue/Received
one year report 11/01/2012 11/01/2012 On Time
18 month report 01/31/2013 02/01/2013 Overdue/Received
two year report 07/31/2013 08/01/2013 Overdue/Received
three year report-final report 07/30/2014 07/30/2014 On Time
four year report 07/31/2015    
five year report 07/31/2016    

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