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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 P050016
Most Recent Protocol Version Approved 07/03/2007
Study Name New Enrollment
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
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 Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a multi-center, prospective cohort study. The first null hypothesis of the study   show the rest ...
Study Population Description Study population is as per device indication.
Sample Size The sample size is 160 procedures.
Data Collection For both primary efficacy endpoints (freedom from revision and composite clinical success), the primary objective   show the rest ...
Followup Visits and Length of Followup Patients will be evaluated preoperatively, and at 6 weeks, 6 months, 12 months and 24   show the rest ...


New Enrollment Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report (New Enrollment) 07/02/2008 06/27/2008 On Time
18 month report (New Enrollment) 12/31/2008 12/31/2008 On Time
21 month report (New Enrollment) 03/31/2009 03/31/2009 On Time
2 year report (New Enrollment) 07/02/2009 07/01/2009 On Time
27 month report (New Enrollment) 10/01/2009 10/01/2009 On Time
30 month report (New Enrollment) 01/05/2010 01/05/2010 On Time
33 month report 04/05/2010 04/02/2010 On Time
3 year report (New Enrollment) 07/02/2010 07/01/2010 On Time
39 month report 09/30/2010 09/30/2010 On Time
42 month report 12/29/2010 12/29/2010 On Time
45 month report 04/01/2011 04/01/2011 On Time
4 year report 07/02/2011 07/11/2011 Overdue/Received
51 month report 10/01/2011 09/29/2011 On Time
54 month report 12/31/2011 12/29/2011 On Time
5 year report 07/01/2012 07/09/2012 Overdue/Received
6 year report 07/01/2013 06/20/2013 On Time
7 year report 07/31/2014    

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