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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 P050009
Current Protocol Accepted 12/16/2005
Study Name OSB Lead-Long Term Study
Study Status Terminated
Study Progress Reason Sponsor withdraws PMA
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is single-arm, prospective cohort. There are no formal study hypotheses. 10 year   show the rest ...
Study Population Description Patients who underwent total hip arthroplasty using a C2 a-Taper Acetabular System ceramic on ceramic   show the rest ...
Sample Size The sample size is 257 patients.
Data Collection Study endpoints include device revision and Harris Hip Score during the first five years of   show the rest ...
Followup Visits and Length of Followup Patients will undergo clinical and radiographic examination for their first five years of follow-up. During   show the rest ...

OSB Lead-Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 12/16/2006 12/15/2006 On Time
2 year report 12/16/2007 12/17/2007 Overdue/Received
3 year report 12/15/2008 12/17/2008 Overdue/Received
4 year report 12/15/2009 12/10/2009 On Time
5 year report 12/15/2010 12/15/2010 On Time
6 year report 12/15/2011 12/15/2011 On Time
7 year report 12/14/2012 12/10/2012 On Time
8 year report 12/14/2013 12/19/2013 Overdue/Received
9 year report 12/14/2014 12/12/2014 On Time

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