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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 P040023
Most Recent Protocol Version Approved 05/03/2005
Study Name Duraloc Long Term
Study Status Revised/Replaced Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a prospective, uncontrolled multi-center study that is designed to evaluate the   show the rest ...
Study Population Description Study population as per device indication. This device is indicated for non-cemented use in primary   show the rest ...
Sample Size A total of 250 patients 10 clinical centers
Data Collection Key endpoints include device survival, Harris Hip Score, and radiographic assessment. During the final 5   show the rest ...
Followup Visits and Length of Followup Each patient will be followed for 10 years. During the first 5 years of patient   show the rest ...


Duraloc Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Study Initiation report 11/10/2005 11/10/2005 On Time
1 year report 05/03/2006 07/25/2006 Overdue/Received
2 year report 07/03/2007 07/16/2007 Overdue/Received
Adverse Device Report 01/15/2008 01/15/2008 On Time
3 year report 05/02/2008 05/07/2008 Overdue/Received
4 year report 07/29/2009 08/04/2009 Overdue/Received

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