New FDA Draft IVD Guidance First For Dx Industry in More Ways Than One | GenomeWeb

The US Food and Drug Administration has issued its first draft guidance for developing and marketing multi-analyte-based diagnostic tests.

The draft, which has at least two accommodations for industry that do not exist for other life-sciences devices or technologies, represents the first document of its kind that may lead to government regulation of multiplexed microarray-based diagnostic products.

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