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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P060023
Current Protocol Accepted 05/12/2009
Study Name Long-Term Study
Study Status Progress Adequate
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 study that involves continued follow-up of the premarket cohort. The   show the rest ...
Study Population Description Study population is as per device indication. This device is indicated in skeletally mature patients   show the rest ...
Sample Size Postoperative data will be collected at 5, 7, and 10 years on a minimum of   show the rest ...
Data Collection The primary outcome variable, overall success, is defined below. A patient will be considered an   show the rest ...
Followup Visits and Length of Followup Data will be collected at 60 months (5 years), 84 months (7 years), and 120   show the rest ...


Long-Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 11/10/2009 11/10/2009 On Time
1 year report 05/12/2010 06/28/2010 Overdue/Received
18 month report 11/10/2010 11/10/2010 On Time
2 year report 06/10/2011 06/10/2011 On Time
3 year report 05/11/2012 05/09/2012 On Time
4 year report 05/11/2013 05/08/2013 On Time
5 year report 06/10/2014 06/10/2014 On Time
6 year report 05/11/2015    
7 year report 05/10/2016    
8 year report 05/10/2017    
9 year report 05/10/2018    
10 year report 05/10/2019    

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