FDA Issues Final Rule on Laboratory Developed Tests
the FDA clarified that In vitro Diagnostic Devices (IVDs), including Laboratory Developed Tests (LDTs), are regulated as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when manufactured by laboratories. This move aims to enhance patient safety by phasing out enforcement discretion for most LDTs over four years, aligning requirements for IVDs regardless of where they are made.
DO NOTIFIED BODIES HAVE THE CAPACITY TO MANAGE THE MDR AND IVDR TRANSITIONS?
While recent information shows that both Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications have been on the rise, there are concerns as to whether the Notified Bodies have the capacity and competency to accommodate this trend. In March of this year, the EU commission released Regulation (EU) 2023/607, with immediate effect. […]
