White Paper

House Discussion Draft Released on Regulatory Approach for In Vitro Clinical Tests


Discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA) recently released.

DAIA would regulate in vitro clinical tests, defined in the draft as a laboratory test protocol or finished product intended for clinical use in the collection, preparation, analysis, or in vitro clinical examination of human specimens for the purpose of identifying, screening, measuring, detecting, predicting, monitoring, or assisting in selecting treatment for a disease or other condition. DAIA is intended to establish a flexible, risk-based approach to regulation of IVCTs.



Elizabeth Guo

Covington & Burling LLP

Elizabeth Guo is an associate in the Food Drug and Device Group with Covington & Burling LLP.

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