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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 P050016
Current Protocol Accepted 11/04/2008
Study Name OSB Lead-Long Term Study
Study Status Progress Adequate
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a multi-center, non-randomized, cohort study, which includes the extended follow-up of the   show the rest ...
Study Population Description Study population is as per device indication.
Sample Size The sample size is up to 448 patients.
Data Collection Data collection includes patient demographic data and medical history. A functional evaluation will be performed   show the rest ...
Followup Visits and Length of Followup Patients will receive clinical and radiographic examination at 3, 4, 5, 8 and 10 postoperative   show the rest ...

OSB Lead-Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report (Long Term) 01/01/2008 01/02/2008 Overdue/Received
1 year report (Long Term) 07/02/2008 06/27/2008 On Time
18 month report (Long Term) 12/31/2008 12/31/2008 On Time
2 year report (Long Term) 07/02/2009 07/02/2009 On Time
3 year report (Long Term) 07/02/2010 07/01/2010 On Time
4 year report (Long Term) 07/02/2011 07/15/2011 Overdue/Received
5 year report (Long Term) 07/01/2012 07/20/2012 On Time
6 year report (Long Term) 07/01/2013 07/26/2013 Overdue/Received
7 year report (Long Term) 08/15/2014 08/07/2014 On Time
8 year report (Long Term) 08/17/2015 08/17/2015 On Time
Final Report 03/31/2017    

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