Just curious, as Class 1 devices do not require premarket notification, would the mfr have to demonstrate 'clinical efficacy' ?
luck, Brian > -----Original Message----- > From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of Jon > Griver > Sent: Tuesday, May 22, 2007 6:56 AM > To: EMC PSTC > Cc: Kim Boll Jensen > Subject: RE: FDA approval > > Kim, > > A short description of the FDA process is given on my site at: > http://www.601help.com/Regulatory/fda.html > > You need both safety and EMC and lot's of other information, including > clinical efficacy. It is not a process for the faint hearted! > > Regards, > > Jon Griver > http://www.601help.com > The Medical Device Designers' Guide to IEC 60601-1 - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.org Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
