Hello Kim, If the scanned image of the skin is going to be used to make a medical diagnosis, you definitely have a medical device, if that is the intended use of the scanner.
I recommend that you look at the FDA classification database to see if your product fits any of the categories at: < http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm > If you cannot find a similar (predicate) device through this database, you need to contact a consultant who is familiar with US FDA medical device requirements. I say this because if you cannot find a predicate device, that is used for a 510(k) notification, you will be automatically classified as a class III device, and would have to do a Premarket Approval (PMA), unless you get your product re-classified under the de Novo process to class I or class II. BTW, to answer your questions, the FDA will want EMC and Product Safety data to support your applications. As for fees, check these web pages: 510(k) < http://www.fda.gov/cdrh/devadvice/314a.html > PMA < http://www.fda.gov/cdrh/devadvice/pma/userfees.html > Best regards, Ron Wellman From: [email protected] [mailto:[email protected]]On Behalf Of Kim Boll Jensen Sent: Tuesday, May 22, 2007 6:46 AM 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 ______________________________________________________________________
