Allen, Your best approach would be to contact the FDA either directly or via an FDA consultant and get a ruling from them. They will want to know precisely what the intended function of the product is, and what 'labelling' you will use, including advertising material. If appropriate, they may even give you guidance on how to word your 'labelling' so that the product would not be considered a medical device.
By the way, even if it's not considered a medical device, hospital electrical codes may require it to comply with IEC 60601-1, due to its proximity to the patient. Best Wishes, Jon Griver http://www.601help.com The Medical Device Developers' Guide to IEC 60601-1 From: "Allen Tudor" <[email protected]> To: <[email protected]> Sent: Wednesday, December 01, 2004 9:25 PM Subject: Is FDA submittal required? > Hi all, > > My product is a flat panel display and keyboard mounted on a pivoting arm so > that the panel and keyboard can be positioned over a hospital bed. The > patient can access the internet or watch TV and the health care personell > can access medical records pertaining to the patient, check for medication > schedules/dosages, and enter data/patient information etc. > > Should this device be submitted to the FDA as a medical device? > > Thanks in advance. > > Allen Tudor > 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/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Ron Pickard: [email protected] Scott Douglas [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
