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www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-c000001-01-vol2.pdf.

Smith & Nephew‘s :Response to Wright Medical Technology‘s Citizen’s  Petition to Deny PPrIA P040033

Smith & Nephew, Inc.  is responding to Wright Medical Technology’s  (WMT) citizen’s petition requesting that the Food and Drug Administration (FDA) deny approval of PMA P040033 for the Birmingham Hip Resurfacing (BHR) System, despite years of data collection and agency review.  The WMT petition is procedurally flawed because FDA’s well-defined premarket application (PMA) review process does not permit third parties to interject themselves by filing a citizen’s petition.  Although interested third parties may request review of an approval order, such requests are permitted only after an approval order has issued, and must be filed as a petition for reconsideration .  Flouting this procedure, WMT has jumped in with a citizen’s petition while the administrative record is incomplete and before FDA has even made a final decision .

WMT citizen’s petition also lacks merit.  It simply rehashes issues concerning the BHR system PMA application that were fully vetted before the expert independent advisory panel.  WMT asserts that an FDA approval would contravene the governing statutes and regulations, but as will be discussed below, this claim is without merit.  As to the scientific issues that WMT raises, the advisory panel was fully justified in finding that the BHR System data provide a reasonable assurance of safety and effectiveness, and FDA would likewise be justified in doing so.  As discussed below, WMT does not present any basis for concluding that an FDA approval should be withheld or that it would be outside the bounds of expert scientific.  judgment .  WMT’s petition should be summarily denied.

Full response – click here Smith & Nephew’s Response to Wright Medical Technology’s Citizen’s 05p-0440-c000001-01-vol2

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