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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 H080005
Current Protocol Accepted 01/03/2012
Study Name OSB Lead-Elana Surgical KitHUD
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Post Approval Registry
Study Population Description All patients selected for a procedure with the Elana Surgical Kit will be part of   show the rest ...
Sample Size It is expected that a site can select between 3-5 patients on an

annual basis. The   show the rest ...
Data Collection Primary endpoint

The ability of the Elana Surgical Kit to retrieve a flap (circular disk of   show the rest ...
Followup Visits and Length of Followup Post-operative

Information will be collected pre-operatively, during the operation and one post operative follow up (>25   show the rest ...

OSB Lead-Elana Surgical KitHUD Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 09/08/2011 11/22/2011 Overdue/Received
one year report 03/09/2012 03/07/2012 On Time
18 month report 09/07/2012 09/05/2012 On Time
two year report 03/09/2013 03/07/2013 On Time
three year report 03/09/2014 03/18/2014 Overdue/Received
four year report 03/09/2015 03/09/2015 On Time
five year report 03/09/2016 03/08/2016 On Time

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