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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 P100047
Most Recent Protocol Version Approved 11/20/2012
Study Name Newly Enrolled (HW-PAS-01)
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 External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: To evaluate the safety and efficacy of the HeartWare System in a commercial setting   show the rest ...
Study Population Description Patients entered into the INTERMACS database who receive a HeartWare System (treatment group) and contemporaneous   show the rest ...
Sample Size 600 HeartWare patients and 600 control patients of continuous flow, intra- corporeal LVADs other than   show the rest ...
Data Collection The primary endpoint is success (alive, transplanted, or explanted for recovery) at 180 days on   show the rest ...
Followup Visits and Length of Followup Two years post implant

Follow-up will occur at discharge, 1 week, 1 month, 3 months, 6   show the rest ...


Newly Enrolled (HW-PAS-01) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 05/21/2013 05/20/2013 On Time
one year report 12/20/2013 12/17/2013 On Time
18 month report 05/21/2014 05/14/2014 On Time
two year report 11/20/2014    
three year report 11/20/2015    
four year report 11/19/2016    
five year report 11/19/2017    

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