In July, the FDA released its revised draft guidance for in vitro diagnostic multivariate index assays (IVDMIAs). The FDA issued a previous guidance last year (see IBO 11/15/06). The draft guidance’s language has been revised to clarify the definition of an IVDMIA and provides examples of tests that are and are not IVDMIAs. The revised guidance also provides an in-depth explanation of the classification and review of IVDMIAs based on the risks of their use. However, the basic definition of an IVDMIA laid out in the initial draft guidance has not changed. Producers of IVDMIAs have up to 18 months after the publication of the final guidance to comply with the FDA’s new regulations. To ease the financial burdens on some companies producing IVDMIAs, the FDA does not plan to regulate IVDMIAs for diseases affecting fewer than 4,000 people in the US per year. Source: FDA

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