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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 P040040
Current Protocol Accepted 03/18/2016
Study Name OSB Lead-Post Approval Study
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective & Retrospective 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 Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21, All Pediatric Patients: 0-21 yrs
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, non-randomized, multi-site clinical study. The primary safety objective is to   show the rest ...
Study Population Description This device is indicated for use in patients with a complex VSD of significant size   show the rest ...
Sample Size One hundred (100) subjects will be enrolled at up to 50 U.S. sites and additional   show the rest ...
Data Collection Primary safety endpoint:

Any major (serious) adverse event within 12 months of the procedure. A serious   show the rest ...
Followup Visits and Length of Followup 5 years

Frequency of Follow-up Assessments

At 30 days, 6 months , one year, and   show the rest ...

OSB Lead-Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 10/01/2008 09/08/2008 On Time
2 year report 09/06/2009 09/03/2009 Overdue
3 year report 09/06/2010 09/07/2010 Overdue/Received
4 year report 09/06/2011 09/06/2011 On Time
5 year report 09/05/2012 09/05/2012 On Time
6 year report 09/05/2013 08/30/2013 On Time
7 year report 09/05/2014 09/05/2014 On Time
8 year report 09/05/2015 09/08/2015 Overdue/Received
9 year report 09/04/2016    

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