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US FDA Electromagnetic Compatibility Guidance Finalized

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.

Last year, FDA released a draft guidance that set out nine specific recommendations regarding electromagnetic compatibility, or EMC, that should be considered by sponsors submitting a premarket submission for electrically powered devices. (See Also see "Avoiding Electromagnetic Interference: FDA Issues Draft Guidance" - Medtech Insight, 2 November, 2015..)

The final version clarifies the guidance by stating the scope includes premarket approval applications (PMAs), humanitarian exemptions, 510(k)s, investigational device...

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