Last year, FDA released a draft guidance that set out nine specific recommendations regarding electromagnetic compatibility, or EMC, that should be considered by sponsors submitting a premarket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 (See Also see "Avoiding Electromagnetic Interference: FDA Issues Draft Guidance" - Medtech Insight, 2 November, 2015..)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