IVD Symbol Draft Guidance Issued By FDA As EU Directive Looms
This article was originally published in The Gray Sheet
Executive Summary
A response to Bio-Rad's citizen petition requesting that FDA allow use of symbols on in vitro diagnostic labeling in place of text is forthcoming
You may also be interested in...
Regulatory News In Brief
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)...
Regulatory News In Brief
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)...
Bio-Rad Defends Labeling Under First Amendment, Prior FDA Inaction
Disclaimers on unified labeling for lab "control products" that list unapproved tests are legal and do not promote off-label use, Bio-Rad maintains in a citizen petition recently filed with FDA