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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 P060018
Current Protocol Accepted 07/16/2007
Study Name OSB Lead-Long-Term Study
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective cohort to continue follow-up of the subjects who participated in (1)   show the rest ...
Study Population Description The study include IDE, CAS and metal ion study subjects. This device is indicated in   show the rest ...
Sample Size A minimum of 200 patients (minimum of 100 patients each from control and PRESTIGE groups)   show the rest ...
Data Collection A patient will be considered an overall success if all of the following conditions are   show the rest ...
Followup Visits and Length of Followup Postoperative data will be collected at 3, 5, and 7 years
Final Study Results
Actual Number of Patients Enrolled 600 (100%)
Actual Number of Sites Enrolled 31 (100%)
Patient Followup Rate The sponsor was expected to follow a minimum of 200 patients (minimum of 100 patients   show the rest ...
Final Safety Findings In terms of cumulative adverse events n=259 (97.7%) of investigational patients had an adverse event

during   show the rest ...
Final Effectiveness Findings The primary end-point for the study was overall success-a composite of safety and effectiveness. Hundred   show the rest ...
Study Strengths and Weaknesses This study provided much needed information on the Prestige long term (7-years) performance. However, the   show the rest ...
Recommendations for Labeling Changes Yes: Long term data on the device safety and effectiveness is available and the labeling   show the rest ...

OSB Lead-Long-Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 01/14/2008 01/14/2008 On Time
1 year report (Long-Term Study) 07/31/2008 07/31/2008 On Time
18 month report (Long-Term Study) 01/13/2009 01/12/2009 On Time
2 year report (Long-Term Study) 08/15/2009 08/14/2009 On Time
3 year report (Long-Term Study) 07/15/2010 07/15/2010 On Time
4 year report (Long-Term Study) 07/15/2011 08/15/2011 On Time
5 year report (Long-Term Study) 07/14/2012 07/13/2012 On Time
6 year report (Long-Term Study)-FINAL 07/14/2013 07/17/2013 Overdue/Received
final report 11/14/2013 11/14/2013 On Time
response to R32 A5-final report 08/12/2015 08/12/2015 On Time

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