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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 H040006
Most Recent Protocol Version Approved 09/05/2006
Study Name Abiocor Artificial Heart
Study Status Other
Study Progress Reason Device not marketed
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 No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective multi-center single armed study. The goal of the study is to   show the rest ...
Study Population Description Study Population: Patients in severe biventricular heart failure and who are not transplant candidates; not   show the rest ...
Sample Size 25 patients, 10 sites
Data Collection The following outcomes will be assessed: 1) Adverse events: including neurologic events, infection, bleeding, renal   show the rest ...
Followup Visits and Length of Followup Post-discharge, patients will be contacted every three months. Patients will be followed until death (while   show the rest ...


Abiocor Artificial Heart Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 03/06/2007 03/09/2007 Overdue/Received
1 year report 09/05/2007 09/06/2007 Overdue/Received
18 month report 03/05/2008 04/21/2008 Overdue/Received
2 year report 09/04/2008 09/04/2008 On Time
30 month report 03/05/2009 03/26/2009 Overdue/Received
3 year report 09/04/2009 09/08/2009 Overdue/Received
42 month report 03/05/2010 03/05/2010 On Time
4 year report 11/03/2010 11/04/2010 Overdue/Received
54 month report 03/04/2011 03/04/2011 On Time
5 year report 09/04/2011 09/07/2011 Overdue/Received
66 month report 04/27/2012 04/27/2012 On Time

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