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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 P090029
Current Protocol Accepted 04/06/2015
Study Name OSB Lead-Enhanced Surveillance Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Enhanced Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Study Objectives- to fully characterize adverse events and

complaints when the device is used in the   show the rest ...
Study Population Description All device users
Sample Size N/A
Data Collection All adverse event data including subsequent surgeries, heterotopic ossification, device malfunction, and other serious device-related   show the rest ...
Followup Visits and Length of Followup The study duration is 10 years.

OSB Lead-Enhanced Surveillance Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 01/22/2015 02/25/2015 Overdue/Received
one year report 07/24/2015 07/27/2015 Overdue/Received
18 month report 01/22/2016 01/29/2016 Overdue/Received
two year report 07/23/2016    
three year report 07/23/2017    
four year report 07/23/2018    
five year report 07/23/2019    

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