On Sat, 2005-04-23 at 16:44 -0500, [EMAIL PROTECTED] wrote:
> Bill Anderson <[EMAIL PROTECTED]> wrote in part:
>
> >But wait, there's more! The FDA deals with more than drugs. Any and all
> >"Devices" count too. Here's an example. Cloth feminine pads are under
> >the regulation of the FDA. If your wife, for example, wants to make them
> >fr herself, the FDA has no say. But try to sell them and you get
> >regulated. You can sell a kit that people have to actually assemble
> >themselves, and be good to go.
>
> No, not even then; see below.
>
> > But assemble it yourself and blammo.
> >Extensive testing is now required. Your materials, your supplies, your
> >environment, the whole thing.
>
> If the kit you sell is INTENDED for people to assemble into a medical
> device, then it too is a medical device, for components of medical devices
> (i.e. intended by the purveyor to make up parts of such devices) are
> themselves medical devices.
>
> I used to work in medical device R&D, so I know.
Figures. Well chalk up another group of citizens "breaking the law".
--
Random Fortune of the moment:
If you wants to get elected president, you'se got to think up some
memoraboble homily so's school kids can be pestered into memorizin'
it, even if they don't know what it means.
-- Walt Kelly, "The Pogo Party"
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