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What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems

An ARUP expert will answer questions about a proposed FDA rule to regulate laboratory-developed tests (LDTs) as medical devices, which will potentially limit patient access to essential medical care.

Webinar: November 29, 2023, 11 AM–NOON (MST)

News

November 21, 2023

ARUP experts seek to increase understanding of the FDA’s proposed rule to regulate lab-developed tests as medical devices and the impact on hospitals and patients during a webinar on November 29.

November 10, 2023

ARUP has gained a Conformité Européenne (CE) mark for AAV5 DetectCDx™ single-site use. The test will aid in determining the eligibility of non-U.S. patients for a new hemophilia A gene therapy.