Lexology October 30, 2023
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency’s general enforcement discretion approach to such devices.
On September 29, 2023, the U.S. Food and Drug Administration (“FDA”) announced a proposed rule to amend its regulations to make explicit its position that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act “including when the manufacturer is a laboratory.” The move, which proposes adding language to 21 CFR ยง 809.3, initiates notice-and-comment rulemaking on a matter garnering both strong opposition and support. If adopted, the rule would considerably shift FDA’s approach to laboratory developed tests (“LDTs”), with significance not only for clinical laboratories...
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