Hi, In the USA, it is the FDA. For most medical products, the FDA determines that your product is Substantially Equivalent to a legally marketed device. This is the FDA 510(k) process. They issue you a letter that allows you to legally market the device.
For EMC, the FDA usually wants to see that you comply with IEC 60601-1-2. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax [email protected] e-mail -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Friday, October 26, 2001 5:15 AM To: [email protected] Subject: FDA Hi all, What is the basic differences between FDA and FCC ? Don't laugh, yes I know it is a silly question, but if you want to certify medical equipment, are the requirements covered in the FDA or in the FCC regulations ? As you understand, within this field, I'm a really novice ........... Best regards Amund Westin, Oslo/Norway ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [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: No longer online until our new server is brought online and the old messages are imported into the new server. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [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: No longer online until our new server is brought online and the old messages are imported into the new server.
