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. In Your Sly Tribe, Robert in the Bronx _______________________________________________ Libnw mailing list Libnw@immosys.com List info and subscriber options: http://immosys.com/mailman/listinfo/libnw Archives: http://immosys.com/mailman//pipermail/libnw
