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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

IVD symbol final guidance issued: FDA retains recommendation that accompanying glossaries for symbols be included as part of package inserts rather than as separate labeling. However, the 1Nov. 30 guidance on "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" withdraws a draft proposal to "exercise enforcement discretion if a company used the symbol that represents 'manufacturer' to satisfy...610.64," a section dealing with the name and address of distributors. "Upon reflection, that symbol does not appear applicable to section 610.64," FDA explains in an accompanying Federal Register notice. The device and biologics centers issued the draft version of the document in October 2003, after industry pressed for symbols in lieu of text to aid harmonization efforts and save space (2"The Gray Sheet" Nov. 3, 2003, p. 6)...

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