Confusing Regulatory Landscape in US Could Spur Caution Among Dx Test Developers | GenomeWeb
The US Food and Drug Administration’s intent to regulate in vitro diagnostic multivariate index assays has made genetic test developers more cautious, even before the agency codifies its goal.
Since the FDA expressed its desire last year to regulate IVDMIAs, genetic test developers have consistently criticized the agency’s approach for regulating laboratory-developed genetic tests as arbitrary, piecemeal, and a potential hindrance to innovation.

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