FDA Offers Even More Detailed Recommendations In EMC Draft Guidance
Four years after finalizing its electromagnetic compatibility (EMC) guidance, the US agency has proposed a draft guidance that would add significantly more details in terms of what regulators want from a sponsor’s premarket application.
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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.
In the final medical device electromagnetic compatibility guidance FDA clarified the scope of applications that could use this guidance and added a recommendation for sponsors to identify and consider the intended use environmental that could affect the EMC of their products.
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