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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 P110008
Current Protocol Accepted 04/23/2013
Study Name Coflex Actual Practice PAS
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Randomized clinical trial
Study Population Description The study population is comprised of patients with radiographic

confirmation of at least moderate degenerative spinal   show the rest ...
Sample Size The sample size is 230 patients. There will be 115 patients in

each group. There will   show the rest ...
Data Collection The primary endpoint is improvement of Oswestry Low Back

Pain Disability Index (ODI) after 24 months   show the rest ...
Followup Visits and Length of Followup Patients will be followed for 2 years.

Patients will be evaluated pre-operatively, and at 3, 12   show the rest ...


Coflex Actual Practice PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 04/17/2013 07/05/2013 Overdue/Received
one year report 12/01/2013 02/14/2014 Overdue/Received
18 month report 04/17/2014 06/13/2014 Overdue/Received
two year report 10/17/2014 11/28/2014 Overdue/Received
three year report 10/17/2015    
four year report 10/16/2016    
five year report 10/16/2017    

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