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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 P050039
Most Recent Protocol Version Approved 12/09/2010
Study Name Novation PAS
Study Status Progress Adequate
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 No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description multi-center, open-label clinical study. Prospective and retrospective enrollment

is allowed.
Study Population Description Patients who are scheduled to undergo total hip arthroplasty with a hard bearing

prosthesis should be   show the rest ...
Sample Size Up to ten (10) centers will participate in this study.

125 hips.
Data Collection The objective of this study is to gather supplementary long-term information regarding

the safety and efficacy   show the rest ...
Followup Visits and Length of Followup

Visit Windows

Subjects shall have visits completed within the following allowable windows:

Visit Visit Window

Preop (baseline) Within   show the rest ...


Novation PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
12 month report 08/03/2011 07/25/2011 On Time
yearly report 08/03/2012 07/02/2012 On Time
Yearly report-active surveillance 08/28/2012 08/28/2012 On Time
year report 08/03/2013 07/05/2013 On Time
12-Month Interim-Active Surveillance Status Report 08/30/2013 08/28/2013 On Time
yearly report 08/30/2014 07/03/2014 On Time
yearly report 08/30/2015    

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