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Home » AdvaMed: Draft Guidance on ISO-10993 Could Delay Reviews
AdvaMed: Draft Guidance on ISO-10993 Could Delay Reviews
July 26, 2013
An FDA draft guidance instructing sponsors on how to use International Organization for Standardization (ISO)-10993 Part 1 to test the potential toxicity of devices that come into direct or indirect contact with the body “may result in even slower development and review times,” AdvaMed says.