forwarding for Constance.
From: Constance R. Brown [mailto:constance.br...@conformityassessment.com.cnchost.com] Sent: Wednesday, July 05, 2000 8:40 AM To: Nick Williams; emc-p...@majordomo.ieee.org Subject: RE: FDA requirements Nick, The best site for all this information is the FDA site itself: www.fda.gov. Click on the medical device section on the home page. Then choose Premarket issues. And, then approval & clearance. That will take you through the classification process & provide you with the various requirements for device approval in order to achieve market clearance. You also should consider the use of recognized standards & the possibility of third-party review. Post market considerations can be found under the GMP/QS section. You should also review the device design & labeling sections. I have included the three classifications for thermometer's for you-so it depends on the specific use of your device. Thermometer, clinical color change, Class I, CFR 880.2900---exempt from a 510k filing Thermometer, electronic, clinical, Class II, CFR 880.2910-requires a 510k filing Thermometer, clinical mercury, Class II, CFR 880.2920-class II-exempt from 510k For Class I devices a premarket notification application (510k) is not required before marketing the device in the US. Nonetheless, the manufacturer is still required to register their establishment by submitting Form FDA 2891, Initial Registration of Device Establishment, and list the generic category of classification name of the device by submitting Form FDA 2892, Device Listing. Some Class II devices are now exempt from premarket notification requirements as the FDA believes its resources would be better used elsewhere. (E.g.: 880.2920). You'll still need to complete the above-mentioned forms. The thermometer, electronic, clinical device (880.2910) is also a candidate for both Accredited Persons & Mutual Recognition Agreement Programs. Let me know if I can provide additional info for you. Kind Regards, Constance Brown constance.br...@conformityassessment.com Tel: 978-524-9890 Fax: 978-524-9898 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson: pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
