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CDRH Industry: FDA announces the Final Guidance titled “Information to Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device”

Today, the U.S. Food and Drug Administration is announcing the availability of the guidance titled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device.”  This final guidance provides FDA’s current thinking about the information that should be provided in a premarket submission to support a claim of EMC for an electrically-powered medical device.  This guidance is intended to ensure that clear and consistent information regarding medical device EMC are provided in premarket submissions to facilitate the review of submissions with EMC claims.

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Center for Devices and Radiological Health
Food and Drug Administration