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FDA Issues Final Guidance On Electromagnetic Compatibility Of Medical Devices

Document finalizes updated 2020 draft

 
• By Brian Bossetta

The US FDA issued its final guidance on electromagnetic compatibility for medical devices providing detailed recommendations to manufacturers submitting premarket applications. The final guidance supersedes the agency’s 2016 guidance, which was updated in 2020.

EMC
• Source: Shutterstock

A newly finalized guidance document from the US Food and Drug Administration lays out the agency’s views on the electromagnetic compatibility (EMC) of medical devices.

The final document, issued 6 June, replaces the agency’s 2016 guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.” The new guidance also seeks to provide further clarity to manufacturers as to what the agency is looking for in premarket submissions of EMC devices than the agency’s 2020 draft

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