• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail
-

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

Show All Studies
Export to ExcelExport to Excel
General
Application Number P970003 S050
Most Recent Protocol Version Approved 08/04/2010
Study Name Registry Study
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 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 an observational, multi-center patient outcome registry to follow the clinical course and outcome   show the rest ...
Study Population Description Study population is as per device indication. The device is indicated for the adjunctive long-term   show the rest ...
Sample Size 500 TRD patients receiving adjunctive VNS Therapy and 500 patients not receiving VNS Therapy. 51   show the rest ...
Data Collection Time until response to treatment is the primary endpoint. Secondary endpoints are time until reponse   show the rest ...
Followup Visits and Length of Followup All of the patients are planned to be followed for 60 months after enrollment. Visits   show the rest ...


Registry Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month registry report 01/13/2006 01/12/2006 On Time
1 year Registry report 07/15/2006 07/12/2006 On Time
18 month registry report 01/13/2007 01/10/2007 On Time
2 year registry report 07/15/2007 07/11/2007 On Time
3 year registry report 08/01/2008 07/31/2008 On Time
42 month registry report 03/09/2009 02/27/2009 On Time
4 year registry report 08/07/2009 08/06/2009 On Time
54 month registry report 02/05/2010 01/29/2010 On Time
5 year registry report 08/06/2010 07/27/2010 On Time
6 year registry report 08/05/2011 08/05/2011 On Time
7 year (84 month) registry report 08/03/2012 08/03/2012 On Time
8 year registry report 08/03/2013 08/02/2013 On Time
9 year report 08/03/2014 08/04/2014 Overdue/Received
10 year report 08/03/2015    

Show All Studies

-
-