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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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Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number P010031 S104
Current Protocol Accepted 08/28/2008
Study Name Enhanced Surveillance
Study Status Completed
General Study Protocol Parameters
Study Design Enhanced Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a prospective, non-randomized, combined cohort of subjects followed in two other   show the rest ...
Study Population Description Study population same as approved product. This device is a software algorithm designed to identify   show the rest ...
Sample Size 3873 subjects from multiple centers in 2 cohorts
Data Collection Data are collected via review of the databases using the device algorithm. Triggers associated with   show the rest ...
Followup Visits and Length of Followup The cohort is followed for two years.
Final Study Results
Actual Number of Patients Enrolled 1779
Actual Number of Sites Enrolled n/a
Patient Followup Rate n/a
Final Safety Findings n/a
Final Effectiveness Findings Of 41 events, 39 were detected by LIA algorithm, giving an estimated sensitivity of 95.1%   show the rest ...
Study Strengths and Weaknesses Not all products were returned for the Return Product Analysis. Of 47 LIA triggers, 21   show the rest ...
Recommendations for Labeling Changes Labeling changes should be accomplished in accordance with the findings of the PAS.

Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 02/26/2009 03/03/2009 Overdue/Received
1 year report 08/28/2009 08/31/2009 Overdue/Received
18 month report 02/26/2010 02/25/2010 On Time
2 year report 08/28/2010 08/23/2010 On Time
Final Report 03/14/2011 03/14/2011 On Time
response to R22 RDEF (final report) 11/01/2011 10/31/2011 On Time

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