On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that signifies an end to its long-standing policy of enforcement discretion vis-a-vis the regulation of laboratory-developed tests (LDTs). This development, which has been keenly watched by legal professionals in the health field and larger corporations, marks a defining shift in policy from the FDA.
According to the proposed stipulations, the FDA aims to expand the definition of “in vitro diagnostic products” (IVDs) under 21 Code of Federal Regulations (CFR) Part 809.3(a). A salient point here is that IVDs will now be classified as devices under the Food, Drug and Cosmetic Act (FDCA), even when the manufacturer of these products is a laboratory.
Furthermore, the proposal by the FDA will mean that corporations and law firms dealing with health-related devices will likely have to adapt to these changes fast!
For further details on the FDA’s proposed rule and its implications, you can read the complete document here.