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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 P100003
Current Protocol Accepted 07/16/2014
Study Name Extended f/u of premarket cohort
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study includes investigational and control patients from the US IDE pivotal study (G050075), which   show the rest ...
Study Population Description Secure C patients and ACDF patients from IDE investigation

Sample Size The IDE study invovled 380/Subjects: 89 non-randomly assigned to

SECURE®-C, 151/Randomized to SECURE®-C, and 140/Randomized to

ACDF   show the rest ...
Data Collection Primary Endpoints

This study is required to evaluate overall success (protocol- specified primary endpoint) for each   show the rest ...
Followup Visits and Length of Followup 7 years



Follow-up is annual (3- 7 year) (±4 months window).



Extended f/u of premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 03/29/2013 03/28/2013 On Time
one year report 10/28/2013 10/29/2013 Overdue/Received
18 month report 03/29/2014 03/28/2014 On Time
two year report 09/28/2014 09/26/2014 On Time
three year report 09/28/2015    
four year report 09/27/2016    
five year report 09/27/2017    

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