FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach.

On October 31, 2023, the US Food and Drug Administration (FDA or the Agency) will host a webinar to provide information regarding a long-anticipated notice of proposed rulemaking published on October 3, 2023, which would amend the Agency’s regulations to formalize FDA’s long-standing position that laboratory-developed tests (LDTs) meet the statutory definition of medical devices and therefore are subject to FDA’s medical device authorities. Historically, FDA has not asserted its medical device authorities over LDTs that meet certain criteria. As a result, most LDTs have been marketed without FDA premarket review or oversight.