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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 P100045
Most Recent Protocol Version Approved 08/29/2014
Study Name Champion Substudy
Study Status Study Pending
Detailed Study Protocol Parameters
Study Design Description Prospective/retrospective multicenter single arm cohort study
Study Population Description Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced   show the rest ...
Sample Size 1,200 enrolled (at least 420 women) at no more than 150 sites

At least 35% of   show the rest ...
Data Collection Primary Safety Endpoints: 1) Freedom from device/system related complications (DSRC) over 2 years in study   show the rest ...
Followup Visits and Length of Followup 24 months

Month 1, Month 6, and every 6 months thereafter for 2 years.

Follow-up visits will   show the rest ...


Champion Substudy Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 11/26/2014    
one year report 05/28/2015    
18 month report 11/26/2015    
two year report 05/27/2016    
three year report 05/27/2017    
four year report 05/27/2018    
five year report 05/27/2019    

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