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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 P120006
Current Protocol Accepted 08/28/2013
Study Name Training Program
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, consecutively enrolling, single-arm, non-randomized, multi- center study
Study Population Description Patients with abdominal aortic aneurysm with vascular morphology suitable for endovascular repair with the Ovation/Ovation   show the rest ...
Sample Size A total 320 subjects comprises of 161 pivotal cohort subjects, all continued access subjects, all   show the rest ...
Data Collection At Implant

¿ Technical failure

¿ Type 1 endoleak

¿ Use of Accessory device



Through 30 days

¿ Serious Adverse Events (SAEs)

¿ Mortality (AAA-related and   show the rest ...
Followup Visits and Length of Followup 30 days

At implant and 30 days



Training Program Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 04/05/2013 04/10/2013 Overdue/Received
one year report 10/05/2013 09/19/2013 On Time
18 month report 04/05/2014 04/02/2014 On Time
two year report 10/05/2014 09/23/2014 On Time
three year report 10/05/2015    
four year report 10/04/2016    
five year report 10/04/2017    

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