IVD "Symbols" Labeling, IFU Proposals Are Signs Of The Times, EDMA Says
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed and the European Diagnostic Manufacturers Association will meet with FDA this summer to discuss the possibility of using a graphical symbols approach to in vitro diagnostics labeling in the U.S.
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IVD Symbols: Diagnostic Group Will Give FDA Time On “Internal Issues”
AdvaMed's Labeling Working Group will distribute a survey to clinical labs by the end of June that includes questions about symbol usage on in vitro diagnostic product labeling
IVD Symbols: Diagnostic Group Will Give FDA Time On “Internal Issues”
AdvaMed's Labeling Working Group will distribute a survey to clinical labs by the end of June that includes questions about symbol usage on in vitro diagnostic product labeling
AdvaMed 2002 Annual Meeting In Brief
Meet Mark Kramer: Former CDRH staff college director becomes FDA's point-of-contact for combination products Feb. 25. Working within the FDA ombudsman's office, Kramer will canvass opinions from internal and external stakeholders, advocate more complex reviews of combination products, and navigate firms' requests for designation. At the AdvaMed 2002 Annual Meeting in Carlsbad, California, Center for Biologics Evaluation & Research Deputy Director Jesse Goodman outlined Kramer's role - to "deal with specific problems, interact with manufacturers, and sort of do a better job of bringing all of us to the table to update intercenter agreements." In addition, Kramer will help develop standard operating procedures for intercenter collaboration and consultation. As the first in a series of public meetings devoted to jurisdictional issues, FDA anticipates hosting a May public meeting on tissue-engineered devices. Kramer's background includes experience working in the device industry and CDRH's Office of Device Evaluation...