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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 P050050
Current Protocol Accepted 05/09/2014
Study Name OSB Lead-Long Term Study
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
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 Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The specific objective of this long-term study is to obtain information on the revision and   show the rest ...
Study Population Description The study population consists of all living subjects who participated in the continued access study.

Device   show the rest ...
Sample Size minimum 125 patients (STAR Ankle recipients)

The comparison of the STAR ankle is to a literature   show the rest ...
Data Collection Primary Effectiveness Endpoint

Device Survivorship (Revision and Removal) at 8 years after implantation

Note: The information   show the rest ...
Followup Visits and Length of Followup 96 months

48 months (± 8 weeks) , 72 months (± 8 weeks), and 96 months   show the rest ...

OSB Lead-Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 11/25/2009 02/17/2010 Overdue/Received
1 year report 05/27/2010 05/28/2010 Overdue/Received
18 month report 11/25/2010 11/29/2010 Overdue/Received
2 year report 05/27/2011 05/27/2011 On Time
3 year report 05/26/2012 05/25/2012 On Time
4 year report 05/26/2013 05/29/2013 Overdue/Received
5 year report 06/25/2014 06/27/2014 Overdue/Received
6 year report 09/30/2015 09/30/2015 On Time
7 year report 07/24/2016 07/22/2016 On Time
8 year report 05/25/2017    

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