Nick, Check this out http://www.fda.gov/cdrh/devadvice/16.html#page_index it will assist in classifying your medical device/equipment for the US market.
Regards, Mark -----Original Message----- From: Nick Williams [mailto:[email protected]] Sent: Tuesday, July 04, 2000 11:15 AM To: [email protected] Subject: FDA requirements Can somebody give me a good pointer for resource in relation to the US FDA requirements (i.e. what is covered, and what the requirements are?) I've been asked to consider what might be required for the sale of a clinical thermometer for consumer use in the US. Regards Nick. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
