• 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.


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

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number P970003 S050
Current Protocol Accepted 06/04/2015
Study Name OSB Lead-Registry Study
Study Status Completed
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 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 a 5-year, prospective, observational, multi-center

patient outcome registry to follow the clinical course and   show the rest ...
Study Population Description The registry will enroll a minimum of 500 Treatment-Resistant Depression (TRD) patients treated with adjunctive   show the rest ...
Sample Size 500 TRD patients treated with adjunctive VNS Therapy and a minimum of 300 TRD patients   show the rest ...
Data Collection Primary Endpoint

Response based on MADRS Assessment: Defined as ¡Ý 50% improvement from baseline in Montgomery   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 ...
Final Study Results
Actual Number of Patients Enrolled 841 (494 VNS & 301 TAU)
Actual Number of Sites Enrolled 61
Patient Followup Rate 40-50%
Final Safety Findings The percentage of patients experiencing a score of 5 or 6 (least favorable) on the   show the rest ...
Final Effectiveness Findings A higher response rate based on MADRS was observed in the VNS treated group vs.   show the rest ...
Study Strengths and Weaknesses Study Strengths:

First study to evaluate safety and effectiveness of adjunctive VNS Therapy in patients with   show the rest ...
Recommendations for Labeling Changes labeling changes are recommended

OSB Lead-Registry Study Schedule

Report Schedule
Date Due
FDA Receipt
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-final report 08/03/2015 07/31/2015 On Time

Show All Studies