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    FDA Guidance Aims to Clarify Development of Medical Countermeasures

    A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical countermeasures. The guidance document, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices , is specifically aimed at those IVDs which are intended to simultaneously detect 20 or more pathogens extracted from a single sam...