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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf.

Dear Mr.  Roberts:

Food and Drug Administration

Rockvilie  MD 20857

This letter responds to your citizen petition (Petition) dated October 29, 2005, submitted on behalf of Wright Medical Technology, Inc.  (Wright).’  You ask {Petition at l} that the Food and Drug Administration (FDA), pursuant to 21 U.S .C.  360e(d), deny approval of Smith & Nephew‘s (SN) premarket approval application (PMA) for the Birmingham Hip Resurfacing (BHR) system (P040033).  Specifically, you ask that FDA determine that SN has not met its statutory burden of providing a reasonable assurance of safety and effectiveness:  Id.

DECISION SUMMARY

Your request that we deny approval of SN’s PMA is denied .  Under the Federal Food, Drug, and Cosmetic Act (Act) and FDA regulations, the agency may approve PMAs where the data and information in support of the approval, when taken as a whole, provides reasonable assurance that the device is safe and effective for its conditions of use.  We find your argument that the use of a “retrospective, uncontrolled case series at a single center by a single physician without any protocol and with incomplete follow-up” as not scientifically valid (March 10, 2006, letter at 16) to represent a mischaracterization of the sufficiency of the scientific evidence, unpersuasive, and contrary to the law.

For the Full Response click hereFDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR 05p-0440-pdn0001-vol2

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