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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 P860057 S029
Current Protocol Accepted 01/24/2014
Study Name Long Term
Study Status Progress Adequate
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, single-arm, multi-center study that will enroll a

minimum of 250 patients implanted with the   show the rest ...
Study Population Description Study Population: Patients must be at least 18 years of age

eligible for mitral valve replacement.   show the rest ...
Sample Size A minimum of 250/Subjects at up to 25/Sites in order to obtain a

minimum of 8   show the rest ...
Data Collection Endpoints include thrombo-embolism, perivascular leak,

hemorrhage, endocarditis, and heart failure. Early AE (within 30 days of   show the rest ...
Followup Visits and Length of Followup 8 years - Patients will be followed at discharge, 6-months, one year, and annually thereafter   show the rest ...


Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 03/02/2009 03/02/2009 On Time
1 year report 08/29/2009 08/27/2009 On Time
18 month report 02/27/2010 02/23/2010 On Time
2 year report 08/29/2010 08/19/2010 On Time
3 year report 08/29/2011 08/29/2011 On Time
4 year report 08/28/2012 08/13/2012 On Time
5 year report 08/28/2013 09/11/2013 Overdue/Received
Correction to Info on 4 Year Report 08/30/2013 08/28/2013 On Time
6 year report 08/28/2014 08/27/2014 On Time
7 year report 08/28/2015    
8 year report 08/27/2016    
9 year report 08/27/2017    

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