From: joel.kent@us.datex-ohmeda.com Sent: Tuesday, December 16, 2003 9:59 PM To: fdadockets@oc.fda.gov Cc: joel.kent@us.datex-ohmeda.com Subject: Docket No. 2003D-0383 Importance: High Comment on : Docket No. 2003D-0383, Draft Guidance for Industry and FDA Staff; Use of Symbols on labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability. Pages 61449-61451 ################################################################################################################################ The scope of the guidance document should be broadened to include the use of these symbols on any prescription use medical device not only for in-vitro diagnostics. The same issues of label size and international regulations are also faced by other medical device manufacturers, therefore the guidance should be broadened to allow use on other devices as well. Joel Kent Datex-Ohmeda Inc. 86 Pilgrim Rd. Needham, MA 02492 e-mail : joel.kent@us.datex-ohmeda.com