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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
Current Protocol Accepted 11/20/2012
Study Name Training Program (HeartWare-PAS-02)
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objectives: To assess the effectiveness of current HeartWare

training procedures for the HeartWare VAS, and to   show the rest ...
Study Population Description Study groups: Patients and operators in the Newly Enrolled

Cohort PAS (HW-PAS-01) including IDE and non-IDE   show the rest ...
Sample Size At least 150 subjects are required to be enrolled at 12 new

centers (non-IDE).

The sample size   show the rest ...
Data Collection Primary effectiveness: outcomes for the IDE Experienced centers and the Non-IDE centers. The analysis involves   show the rest ...
Followup Visits and Length of Followup 24 months post-implant.

Baseline - prior to implant, then follow-up will be conducted at 1 week,   show the rest ...


Training Program (HeartWare-PAS-02) 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 05/16/2014 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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