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Smith & Nephew BHR FDA-required 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.
- Guidance Document: “Procedures for Handling Post-Approval Studies Imposed by PMA Order”
- PAS Webpage FAQs
- Letter to IRB Chairs (formerly referred to as “IRB Letter from Dr. Schultz (dated 2/9/09)”
- Letter to PAS Participants
- Letter to PAS Investigators
- Post-Approval Studies Workshops
Phone: (301) 796-6134
Fax: (301) 847-8140
UK Study Schedule
Links on this page:
Page Last Updated: 06/29/2012
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
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- Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
- Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL (earlsview.com)
- FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033 (earlsview.com)
- Smith & Nephew’s :Response to Wright Medical Technology’s Citizen’s Petition to Deny PPrIA P040033 (earlsview.com)
- Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
- Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA (earlsview.com)
- SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf (earlsview.com)
- FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew (earlsview.com)
- Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR (earlsview.com)