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New EMC Guidance Released by FDA

05 November 2015

Medical Device Alert

On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices," describing the types of EMC information that should be provided in a premarket submission for electrically powered medical devices.

Read More: New EMC Guidance Released by FDA


Chan Lee

Chan Lee

Director of Regulatory Sciences
Washington, D.C.

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