Draft guidance on EMC

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance on EMC entitled ‘‘Electromagnetic Compatibility (EMC) of Medical Devices.’’

This new “draft” guidance document is intended to recommend information that should be provided in a premarket submissions to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions.

This new “draft” guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled ‘‘Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices’’ published July 11, 2016 (2016 EMC guidance).

This draft guidance, when final, will replace the FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” (hereafter referred to as the 2016 EMC guidance), published July 11, 2016.

November 17, 2020 Federal Register Notice:  2020-11-17-Federal-Register-Notice

The New Draft Guidance:  2020-draft-Electromagnetic-Compatibility-EMC-of-Medical-Devices

The 2016 guidance: 2016-Info-to-Support-a-Claim-of-Electromagnetic-Compatibility-(EMC)-of-Electrically-Powered-Medical-Devices

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

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