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FDA releases MDx draft guidance
May 2013
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SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) has issued a new draft guidance, Molecular Diagnostic Instruments with Combined Functions, that seeks to provide clarification regarding the standards by which a specific subset of medical diagnostic tests will be assessed. The document calls molecular diagnostic instruments "critical components of certain in-vitro diagnostic devices" and notes that they "may also be used for additional purposes that do not require FDA approval or clearance." The FDA added that "it has determined that such devices may be approved even if they have functions for which the sponsor does not need clearance or approval," though measures need to be in place to ensure unapproved functions do not interfere with approved functions, and clarity is required so as not to confuse users.


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