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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Biomet warning letter: The firm says it has responded to a recent FDA 1warning letter charging that its Signature personalized patient care system is being marketed without clearance or approval. Biomet believes the system, which is manufactured for Biomet by Materialise NV, is "appropriately marketed" under a 510(k). The company says it explained its reasoning in its unreleased Aug. 3 response letter and is awaiting a formal reply from the agency. FDA posted the July 27 warning letter online last week. The signature employs imaging scans to produce patient-specific tools for use in knee-replacement surgery

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