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Avoiding Electromagnetic Interference: FDA Issues Draft Guidance

The draft lists nine elements, including a summary of testing and results, that FDA wants to see from manufacturers to show new electrical devices pose no electromagnetic interference risk.

FDA has set out nine specific boxes that need to be checked for a company to claim electromagnetic compatibility in device applications in a draft guidance document released Nov. 2.

The guidance, which would apply to all electrically powered devices, looks at electromagnetic compatibility (EMC) in terms of how a...

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