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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 P100009
Most Recent Protocol Version Approved 06/13/2014
Study Name Device Registry
Study Status Study Pending
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objectives: to assess long term safety and effectiveness of the

MitraClip device in a broad patient   show the rest ...
Study Population Description Patients who have been determined to be at prohibitive risk for

mitral valve surgery by a   show the rest ...
Sample Size Subjects: 2,000 MitraClip patients consecutively entered into the TVT Registry.



Sites: This study will include all   show the rest ...
Data Collection Primary Safety/Effectiveness Endpoints:

The following endpoints will be reported through 1 year follow-up

from data extracted from   show the rest ...
Followup Visits and Length of Followup 5 years

Discharge, 30 days, 1 year annually through 5 years


Device Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 04/24/2014   Overdue
one year report 10/24/2014    
18 month report 04/24/2015    
two year report 10/24/2015    
three year report 10/23/2016    
four year report 10/23/2017    
five year report 10/23/2018    

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