Study findings could provide blueprint for regulating lab-developed diagnostic tests

Diagnostic tests developed in-house in hospital laboratories are not currently regulated by the Food and Drug Administration (FDA), unlike those sold by manufacturers. A new study suggests that temporary deviations from FDA policy in response to the COVID-19 pandemic offer a look at what regulation of these tests by the agency might look like. Findings from this study could inform legislation aimed at regulating lab-developed tests.

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