FDA Offers Even More Detailed Recommendations In EMC Draft Guidance
Four years after finalizing its electromagnetic compatibility (EMC) guidance, the US agency has proposed a draft guidance that would add significantly more details in terms of what regulators want from a sponsor’s premarket application.
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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.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.