Nick - this sounds like one of those electric skin/muscle toner devices.
While I didn't find specific reference to this type of device, it appears to be treated as a medical device and not a cosmetic. Refer to http://www.cfsan.fda.gov/~dms/cos-derm.html for another type of product that was misidentified. The term ''device'' (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is - (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. [FD&C Act, section 201 (h)] It appears your client's device may fit into definition (3). To get a clear idea, refer to http://www.fda.gov/cdrh/dsma/dsmastaf.html and contact the FDA directly. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA [email protected] > -----Original Message----- > From: Nick Williams > Sent: Wednesday, April 09, 2003 3:51 AM > > I've been asked to take a look at the > requirements for a beauty > treatment product which the client wants to push > for the US market. > It works by passing a small current through the skin. > > The client is adamant that this is not a medical > device in the sense > of the EU Medical Devices requirements since they > make no therapeutic > claims. We have not been responsible for CE > marking it so I'm > reserving my own judgement on this point, but I'm > certainly not going > to assume that the semantic same work around will > provide a release > from the applicable legislative requirements in the US. > > I've spent sometime looking at the FDA site this > morning, but I'm > having trouble find stuff which might be useful > in among the vast > amount of information on true medical devices and > on cosmetics. This > unit might best be described as a 'cosmetic > device' If there's > someone out there who can point me to a quick > primer which gives > details of what the FDA consider to be within the > scope of their > remit, and what the requirements are for > equipment which is within > their remit, this would help immensely in getting > to grips with the > project. > > Thanks > > Nick. > > P.S. As to whether it actually works or not, > well, I haven't seen any > changes yet, but maybe I'm just too beautiful already! > This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
