On July 11th the FDA came out with a Draft Guidance "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices".
Our company has a Class II BBK Software medical device. When reviewing the guidance it is difficult to see how the FDA would expect the manufacturer of a software product to have to demonstrate electromagnetic compatibility testing in the hospital environment, when it's the physical device that may cause the interference, not the software. However, one of our competitors new 510(k) summary for their BBK product - specifically for the mobile platform - shows they performed EMC testing.
We are in the process of planning a new 510(k) submission and are not sure if we need to provide supporting data for EMC, as we can't quite connect the dots between software and EMC, nor do we want to claim EMC. (It is my understanding that the FDA requested from our competitor supporting data of EMC). How would you handle this? Would you just omit and see if the FDA requests it? Can anyone provide any correlations between BBK Software and EMC that maybe we haven't thought of? Thank you
Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470201.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
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Christine
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