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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 P060037
Most Recent Protocol Version Approved 08/14/2014
Study Name 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 & Historical 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, multi-center, parallel group, controlled post-approval study comparing the clinical performance of   show the rest ...
Study Population Description Study population is as per device indication. This device is indicated for patients with severe   show the rest ...
Sample Size The sample size is 400 patients. Group 1 will consist of approximately 300 patients already   show the rest ...
Data Collection A composite clinical success, defined by the following criteria, will be used as the primary   show the rest ...
Followup Visits and Length of Followup The patients will be followed at 6 weeks, 6 months and at annual increments up   show the rest ...


Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Long term study 6 month report 06/09/2008 05/22/2008 On Time
Long term study 1 year report 12/09/2008 11/26/2008 On Time
Long term study 18 month report 06/09/2009 06/03/2009 On Time
Long term study 2 year report 12/09/2009 12/09/2009 On Time
Long term study 3 year report 12/09/2010 12/08/2010 On Time
Long term study 4 year report 12/09/2011 12/06/2011 On Time
Long term study 5 year report 12/08/2012 12/05/2012 On Time
Long term study 6 year report 12/08/2013 12/06/2013 On Time
Long term study 7 year report 12/08/2014    
Long term study 8 year report 12/08/2015    
Long term study 9 year report 12/07/2016    
Long term study 10 year report 12/07/2017    

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