FDA Proposes Exempting Medical Devices from Premarket Notification

The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and II medical devices from premarket submission requirements.

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Comments (1)
"[...]"This is big news and a huge boost to the mHealth industry," said Bradley Merrill Thompson[...]"

Sorry, perhaps I'm missing something. How does this draft guidance pertain at all to mHealth?

Per the definition of "mHealth", from Wikipedia, the free encyclopedia: "mHealth (also written as m-health) is an abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices."[1]

Looking at the list of Class I and Class II devices included in the guidance, mHealth would seem to be excluded.

In fact, in the guidance, in instances where a device is a computer device, the guidance has the following caveat for each: "If device contains software to analyze clinical implication of the measurement, a 510(k) will be required."

Unless mHealth applies to bandage and gauze, patient restraints, denture fitting tools, or hemorrhoid prevention pressure wedges, this is not big news for anything related to mHealth.

"[...]"It shows that FDA is being extremely practical in reviewing its own practices and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources. My hat is off to FDA."[...]"

I agree that it is nice to see that the FDA can be practical and pragmatic in its diligence.

[1] mHealth, from Wikipedia, the free encyclopedia en.wikipedia.org/wiki/MHealth
Posted by Ken W | Tuesday, August 05 2014 at 12:49PM ET
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