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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 P100028
Current Protocol Accepted 12/05/2011
Study Name REFORM
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Final Study Results
Actual Number of Patients Enrolled 100
Actual Number of Sites Enrolled 7
Patient Followup Rate 95%
Final Safety Findings No significant safety problems were reported at 36 months. A clinically significant decrease in systolic   show the rest ...
Final Effectiveness Findings The rate of the primary endpoint was 91.7% and the lower limit of the 95%   show the rest ...
Study Strengths and Weaknesses Results provide further evidence of the clinical utility and safety of this device.

Recommendations for Labeling Changes Post-approval study findings should be part of the device labeling, including the following key safety   show the rest ...

REFORM Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 07/15/2011 07/13/2011 On Time
one year report 01/14/2012 01/13/2012 On Time
18 month report 07/14/2012 07/06/2012 On Time
two year report-FINAL 01/25/2013 01/22/2013 On Time

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