Theodore Sullivan

Theodore Sullivan

Quarles & Brady LLP

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FDA Publishes Final Rule on Regulation of Lab-Developed Tests

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

5/13/2024  /  Clinical Laboratories , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Healthcare , Laboratory Developed Tests , Life Sciences , Medical Devices , Pharmaceutical Industry , Proposed Rules
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