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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 H100004
Most Recent Protocol Version Approved 07/27/2012
Study Name All Comers Registry
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description The study will be an ¿all-comers¿ prospective registry
Study Population Description Patients implanted with the EXCOR Pediatric VAD per indications for use
Sample Size 49 patients (39 for complete follow-up), 10 to 50 sites
Data Collection Primary safety: serious adverse event rates of

¿ Major Bleeding

¿ Cardiac Arrhythmias

¿ Pericardial Fluid Collection (with   show the rest ...
Followup Visits and Length of Followup 24 months post-implant

Pre-implant, Discharge, Post-implant at 3 & 6 weeks, 3, 6, 12, and 24   show the rest ...


All Comers Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 01/27/2013 02/11/2013 Overdue/Received
one year report 07/27/2013 07/31/2013 Overdue/Received
18 month report 02/26/2014 02/26/2014 On Time
two year report 07/27/2014 07/28/2014 Overdue/Received
three year report 07/27/2015    

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