The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more
Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Combination Products (OCP) published the final guidance “Principles of Premarket Pathways for Combination Products,” which provides FDA’s current high-level...more