(October 2, 2023, 11:42 AM EDT) -- WASHINGTON, D.C. — Because laboratory developed tests (LDT) are often used in making health care decisions, the U.S. Food and Drug Administration in a Sept. 29 press release proposed a new rule to designate in vitro diagnostic products as devices under the Food, Drug and Cosmetic Act (FDCA) to “help ensure that healthcare decisions are made based on test results patients can trust.”...