jueves, 25 de septiembre de 2014

CDRH Industry: Policy Clarification for Certain Fluoroscopic Equipment Requirements - Draft Guidance for Industry and FDA Staff

A draft guidance has been posted titled, "Policy Clarification for Certain Fluoroscopic Equipment Requirements."  This document describes FDA’s intent to clarify the application of certain aspects of the performance standard requirements in 21 CFR 1020.32 for fluoroscopic equipment, when the manufacturer has otherwise complied with certain International Electrotechnical Commission (IEC) standards. Because conformance to certain IEC standards identified in this draft guidance adequately addresses those concerns intended to be addressed by the requirements of 21 CFR 1020.32, FDA does not intend to consider whether firms that provide a declaration of conformity and indicate compliance with applicable IEC standards also comply with 21 CFR 1020.32.  To view the draft guidance, please see:http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM415845.pdf

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