Industry to U.S. FDA: Draft Guidance on ISO-10993 Could Delay Reviews

International Medical Device Regulatory Monitor
A U.S. Food and Drug Administration draft guidance instructing sponsors on how to use International Organization for Standardization (ISO)-10993 Part 1 to test the potential toxicity of devices that come into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.

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