Posted on 09/25/2013 4:37:58 AM PDT by SoFloFreeper
The US Food and Drug Administration will begin regulating a heightened category of mobile applications that run on smartphones that will function as traditional medical devices.
The FDA said Monday it will focus on health apps that turn smartphones into medical devices, such as a heart monitor or blood pressure gauge, or serve as an accessory to an existing device.
The agency said most wellness apps that are designed to help people stay healthy don’t pose much risk if they malfunction and thus won’t be federally regulated.
Industry analysts say about 17,000 medical apps...
(Excerpt) Read more at rt.com ...
Cold comfort.
My take is that this sort of over reaching violates the 1st Amendment.
There’s nothing that they won’t put there ungloved, dirty hand up into, is there?
Does this mean added taxes to smartphones? If it’s a medical device, Obamacare taxes it, right?
I work in this industry if it is a device that provides information, diagnositics, or funtionality the regulations (CFR 820 series) already cover it - there are different classes of devices based on risk. They are just once again selectively imposing the regulations on those they choose.
Isn’t there a tax on medical devices? How long before every smart phone has a tax placed on it, just in case it is ever used as a medical device?
Would it not be nice if GOVERNMENT were regulated as they can and do a million times more damage than a cell phone app?
Oh, wait, we used to have a very simple regulation for government, the US CONSTITUTION where WE THE PEOPLE give government limited powers and they are NOT entitled to anything else.
It would be refreshing if the next crop of politicians were to take a pledge to adhere to the letter of Constitutional law as defined by the founders in the Federalist papers and would promise to resign should they ever violate that trust.
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