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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 P030053
Current Protocol Accepted 11/17/2006
Study Name Device Failure Study
Study Status Other
Study Progress Reason Other reason
General Study Protocol Parameters
Study Design Bench/Lab Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The device failure study involves two components. The first component involves the collection of implant/surgery   show the rest ...
Study Population Description All explanted devices are to be returned to Mentor and analyzed and tested
Sample Size All returned devices are analyzed.
Data Collection An analysis was performed on the following categories to identify specific trends correlating to device   show the rest ...
Followup Visits and Length of Followup There is no patient follow-up in this study


Device Failure Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
2 year report 11/16/2008 11/14/2008 On Time
3 year report 11/16/2009 11/16/2009 On Time
4 year report 11/16/2010 11/09/2010 On Time
5 year report 11/16/2011 11/09/2011 On Time
6 year report 11/15/2012 11/15/2012 On Time
7 year report 11/15/2013 11/12/2013 On Time
Change in Report Requirements/Study Status 09/10/2014   On Time

* Sponsor is reporting failure study data in the regular PMA Annual Report.

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