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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 P070001
Current Protocol Accepted 08/12/2008
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 Concurrent Control
Analysis Type Analytical
Study Population 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 population is as per device indication. The study includes IDE and CAS subjects.   show the rest ...
Sample Size 239 ProDiscTM -C (103 Randomized and 136 Continued Access) and 106 ACDF patients for a   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 Data will be collected at 36, 48, 60, 72 and 84 months postoperative

OSB Lead-Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
Long term study 6 month report 06/16/2008 06/18/2008 Overdue/Received
1 year report 12/16/2008 12/17/2008 Overdue/Received
18 month report 06/16/2009 06/18/2009 Overdue/Received
2 year report 12/16/2009 12/22/2009 Overdue/Received
3 year report 12/24/2010 12/23/2010 On Time
4 year report 12/16/2011 12/19/2011 Overdue/Received
5 year report 12/15/2012 12/17/2012 Overdue/Received
6 year report 12/15/2013 12/13/2013 On Time
7 year report 12/15/2014 12/15/2014 On Time
audit report 10/16/2015 10/15/2015 On Time
audit update report 01/16/2016 01/15/2016 On Time
final report 08/31/2016    

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