FDA Draft Guidance on RUO/IUO Products Proposes Tough Changes for Industry Players | GenomeWeb

Originally published June 3.

By Turna Ray

The US Food and Drug Administration this week issued a new draft guidance on the marketing of research-use-only and investigational-use-only in vitro diagnostic products in an effort to close a regulatory loophole that has allowed companies to commercialize diagnostics by circumventing the agency's medical device rules.

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