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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 P040051
Current Protocol Accepted 05/12/2006
Study Name 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 Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is a prospective cohort. This 10-year postapproval study would be conducted to   show the rest ...
Study Population Description Patients who have been implanted with Stelkast Surpass Acetabular System is a ceramic/ceramic acetabular bearing   show the rest ...
Sample Size 300 subjects enrolled
Data Collection Study endpoints include device revision and Harris Hip Score during the first five years of   show the rest ...
Followup Visits and Length of Followup Patients will undergo clinical and radiographic examination for their first five ears of follow-up. During   show the rest ...


Long term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 05/12/2007 05/10/2007 On Time
2 year report 05/11/2008 05/07/2008 On Time
3 year report 05/11/2009 05/06/2009 On Time
5 year report 05/11/2011 05/10/2011 On Time

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