Hello Nick, I'd be curious as to what claims the manufacturer makes for this beauty treatment product. That may determine one thing in regards to potential misbranding under FDA regulations but if there are similar devices already on the market in the USA, I would check to see how they are classified, if at all. However, check out the following URL:
http://www.accessdata.fda.gov/scripts/c rh/cfdocs/cfPCD/classification.cfm?ID=2479 This device is a Class II device and requires pre-market notification to the FDA by submitting a 510(k). Also, there is no such thing as a cosmetic device. It is either a cosmetic, a medical device, or a combination product. Combination products are handled by the Office of Combination Products at: http://www.fda.gov/oc/combination/ Best regards, Ron Wellman At 11:51 AM 4/9/2003 +0100, Nick Williams wrote: >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
