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The FDA is explicitly trying to avoid regulating things like smart watches. They're all but begging companies like Fitbit to be careful in their marketing to avoid forcing the FDA to act on the claims.

http://www.theverge.com/2015/6/24/8836049/fda-regulation-hea...

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Perhaps I should have been more careful saying "like smart watches" then. I meant devices in general ranging the gamut from NiBP machines to SpO2 machines to smart watches. Most of these have far less impact on far fewer people than drugs or food, and yet the FDA spends a huge amount of resources regulating them, even trying to walk through software development methodologies. This is something I've seen first hand working at several sites that make such devices. So perhaps they're trying to scare a few particular vendors out of that specific arena, but on the whole they've got that industry tangled in a huge amount of bureaucracy.

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