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 From: [email protected] [mailto:[email protected]]On Behalf Of Kim Boll Jensen Sent: Tuesday, May 22, 2007 4:46 PM To: EMC PSTC Subject: FDA approval Hi Could some one help me with data on FDA approval of medical equipment. Very short description on approval process and Fee's. Does they require accredited EMC and electrical safety approvals? The product is a optical scanner (like a foto copier machine) which is scanning the patients skin through a glass. Best regards, Kim Boll Jensen Bolls Rådgivning Ved Gadekæret 11F DK-3660 Stenløse Tlf.: 48 18 35 66 Fax: 48 18 35 30 Mobil: 22 99 69 91 E-mail: [email protected] web: www.bolls.dk - 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 [email protected] 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 [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc - 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 [email protected] 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 [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] 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 ______________________________________________________________________
