FDA Issues Final Rule, Confirming IVDs are Devices Under the FD&C Act
The United States Food and Drug Administration (FDA) recently published a final rule, making it explicit that in vitro diagnostic products (IVDs) are considered devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) – including in situations where the manufacturer of the IVD is a laboratory. The FDA simultaneously issued targeted…
Read More...