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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 P030042
Most Recent Protocol Version Approved 07/16/2010
Study Name ConservePlus Longer-Term PAS
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 Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multi-center, prospective, historically controlled
Study Population Description Patients who were previously enrolled in the CONSERVE Plus Total Resurfacing Hip System IDE
Sample Size 353 patients
Data Collection The primary endpoint is clinical success at 120 months post-operative for each patient.
Followup Visits and Length of Followup Patients will undergo clinical and radiographic evaluation post-operatively at years 5,8, & 10. Patients will   show the rest ...


ConservePlus Longer-Term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 01/16/2011 01/12/2011 On Time
1 year report 05/04/2011 05/06/2011 Overdue/Received
18 month report 01/13/2012 01/13/2012 On Time
2 year report 05/16/2012 12/19/2012 Overdue/Received
3 year report 05/16/2013   Overdue
4 year report 05/16/2014    
5 year report 05/16/2015    

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