Laboratory Tests Define Why The Uvex Pheos Cx2 Protects Better

What does the FDA’s final rule on LDTs change?The rule makes it explicit that in vitro diagnostics (IVDs) that are manufactured by clinical laboratories—i.e., laboratory-developed tests (LDTs)—are considered devices under the Federal Food, Drug, and Cosmetic Act (FDCA). IVDs are tests performed on samples such as blood or tissue that have been taken from the human body. LDTs are designed ...