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FDA Offers Even More Detailed Recommendations In EMC Draft Guidance

Four years after finalizing its electromagnetic compatibility (EMC) guidance, the US agency has proposed a draft guidance that would add significantly more details in terms of what regulators want from a sponsor’s premarket application.

FDA entrance sign 2016

The US Food and Drug Administration has proposed an electromagnetic compatibility (EMC) guidance that adds a lot more detail about what regulators want to see from sponsors in premarket applications.

The guidance applies to all electrically powered devices and looks at EMC in terms of how a device should function in its use environment. This includes being immune to electromagnetic disturbances, as well as not generating excessive electromagnetic noise that might interfere with other devices

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