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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 P070026 S004
Most Recent Protocol Version Approved 07/02/2013
Study Name Long-Term F/U of IDE COC36 patients
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 No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective single cohort study (non-controlled,

non-randomized, multicenter study).

  show the rest ...
Study Population Description It is anticipated that up to 80 subjects from the IDE study implanted with the   show the rest ...
Sample Size A total of 170 subjects from up to five (5) sites will participate. These sites   show the rest ...
Data Collection Primary endpoint:

Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10 years post-operatively.



Secondary   show the rest ...
Followup Visits and Length of Followup 10 years

Subjects will be seen for a clinic visit at the time of consent (approximately

5   show the rest ...


Long-Term F/U of IDE COC36 patients Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 10/01/2013 10/01/2013 On Time
one year report 04/02/2014 04/02/2014 On Time
18 month report 10/01/2014    
two year report 04/02/2015    
three year report 04/01/2016    
four year report 04/01/2017    
five year report 04/01/2018    

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