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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 P100023
Current Protocol Accepted 08/28/2014
Study Name ION Post Approval Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center cohort study
Study Population Description Newly Enrolled Post-approval Study Population

Consecutive patients who are eligible to receive a TAXUS Element Stent   show the rest ...
Sample Size The ION US PAS uses data from their newly enrolled subjects and other ION

studies.

The newly   show the rest ...
Data Collection Primary Endpoints

The 12-month CD/MI rate for ION



Secondary Endpoints

Annual increase in Academic Research Consortium (ARC) (definite/probable)   show the rest ...
Followup Visits and Length of Followup 3 years

30-Day, 6-Month, and 1, 2, and 3 Year Follow-Up



ION Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 10/21/2011 10/21/2011 On Time
1 year report 04/21/2012 04/17/2012 On Time
18 month report 10/20/2012 10/19/2012 On Time
2 year report 04/21/2013 04/17/2013 On Time
3 year report 04/21/2014 04/16/2014 On Time
Final Report 08/21/2015    

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