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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 06/12/2012
Study Name New England Baptist Hospital Joint Registry
Study Status Terminated
Study Progress Reason Sponsor withdraws PMA
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Registry study
Study Population Description The study population is comprised of patients who receive the Duraloc Option hip in the   show the rest ...
Sample Size The sample size is 225 patients.
Data Collection The primary endpoint is device revision.
Followup Visits and Length of Followup The length of follow-up is 5 years Follow-up visits will occur per standard medical practice.


New England Baptist Hospital Joint Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Report 07/03/2012 06/26/2012 On Time
3 year report 05/17/2013 05/30/2013 Overdue/Received
4 year report 05/17/2014   Overdue

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