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In 2021, the FDA established the "Safer Technologies Program" (STeP) to cover medical devices that do not qualify for the Breakthrough Devices Program.
In November 2023, the FDA informed public the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China, that are used for injecting fluids into, or withdrawing fluids from, the body.
The FDA cleared the first over-the-counter (OTC) continuous glucose monitoring system (CGM) on March 5, 2024.
FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list on March 21, 2024.