Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration.
The proposed rule seeks to amend the FDA’s regulations to make explicit that In Vitro Diagnostic Products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act. This is when the manufacturer of the IVD is a laboratory.
The FDA is also proposing a new policy under which it intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach. However, the FDA has said this rule will not apply to all LDTs currently on the market.
