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FDA Single-Use Device Reuse Policy Could Be More Stringent By Spring

This article was originally published in The Gray Sheet

Executive Summary

FDA's policy exempting single-use device reprocessors from requiring 510(k) clearance may undergo a significant reconsideration in the Center for Devices and Radiological Health by next spring, Office of Compliance Special Assistant to the Director Caspar Uldricks told attendees of the Food & Drug Law Institute's 42nd Annual Education Conference Dec. 17 in Washington, D.C.

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