Post-approval studies (PAS) are one mechanism by which FDA can obtain longer-term safety and/or effectiveness data for a device as a condition of approval for a premarket application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process.
However, PAS is not a substitute for obtaining the necessary premarket information to support PMA, HDE, or PDP approval.
The three hip resurfacing systems were approved by FDA and are subject to PAS conditions of approval. The study protocols for each of the conditions of approval are outlined below. All of the information in these tables is available at the PAS public webpage:
- FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
- Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
- Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (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)
- P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices (earlsview.com)
- Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR (earlsview.com)
- Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA (earlsview.com)
- Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL (earlsview.com)
- FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew (earlsview.com)