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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 P040040
Most Recent Protocol Version Approved 10/01/2010
Study Name Post Approval Study
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
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 Historical Control
Analysis Type Descriptive
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 and efficacy endpoints   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 100 patients 40 sites
Data Collection The primary effectiveness endpoint include technical success, closure success, and acute procedure success. Technical success   show the rest ...
Followup Visits and Length of Followup This study will enroll a maximum of 100 subjects at a maximum of 40 sites   show the rest ...


Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
9 year report 09/04/2016    

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