US FDA announces amendment to Food Drug and Cosmetic Act to include IVDs in scope
THE WHAT? The US FDA has clarified that in-vitro diagnosis products (IVDs) are devices under the Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. THE DETAILS The change has been prompted by the wider use of laboratory developed tests (LDTs) for a larger and more diverse population. Furthermore, […]