Hello Peter, This may be similar to the product in question:
http://www.alliedhealth.net/micro_ablation.htm Best regards, Ron Wellman At 10:12 AM 4/9/2003 -0700, Peter L. Tarver wrote: >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 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
