On September 29, 2023, the Food and Drug Administration (FDA) released a new proposed rule outlining the regulation of laboratory-developed tests (LDTs) as medical devices. Unlike past proposals, the FDA has taken a simple approach: laboratories developing LDTs for clinical use are manufacturing in vitro diagnostic medical devices (IVDs) for commercial distribution and, therefore, must eventually comply with the FDA's already-established IVD requirements.
In this webinar, Epstein Becker Green attorneys James Boiani and Megan Robertson explore subjects such as the FDA's proposed regulatory amendment, the phaseout policy applicable to IVDs manufactured and offered as LDTs, and the minimum added requirements for LDTs as medical devices.
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