Re: Status of uw-prism packaging for Debian
On 8/1/2014 1:56 AM, Andreas Tille wrote:
> What do you think?
I can't tell if 510(k) clearance would be required, or not.
That is why you need to talk to lawyers that know what the FDA means,
when it says something.
A decade ago, I created a spreadsheet that determines the optimal
nutritional intake for an individual, given certain conditions. About
seven years ago, the legal advice I was given was: "It can be
distributed, with a number of explicitly stated disclaimers, but even
so, distribution might run afoul of other regulations of other Federal,
State, or local agencies, including the FDA. The only way to ensure that
it is not being distributed in violation of FDA regulations, would be to
submit it to the FDA, for certification."
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