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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 P110010
Current Protocol Accepted 05/11/2012
Study Name Continued F/u of Premarket Cohort
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description ¿ Workhorse (WH) Trial is a prospective, randomized, controlled, single blind, multicenter, non-inferiority trial

¿ Small Vessel (SV)   show the rest ...
Study Population Description Continued follow-up of the premarket cohorts:

¿ WH - Subjects with a maximum of 2 de novo   show the rest ...
Sample Size ¿ WH ¿ 1,532

¿ SV ¿ 94

¿ PK ¿ 20-30

Approximately 85 sites in the US, 50 in Europe,   show the rest ...
Data Collection ¿ WH ¿ target lesion failure (TLF), MI, or death at 12 months

¿ SV - TLF   show the rest ...
Followup Visits and Length of Followup Through 5 years post-procedure

12 months, 18 months, 2 years, 3 years, 4 years, and 5   show the rest ...


Continued F/u of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 05/22/2012 05/21/2012 On Time
one year report 11/21/2012 11/14/2012 On Time
18 month report 06/01/2013 05/23/2013 On Time
two year report 11/21/2013 11/21/2013 On Time
three year report 11/21/2014    
four year report 11/21/2015    
five year report 11/21/2016    

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