The FDA released a draft guidance on March 13, 2024, aiming to update its existing guidance on the cybersecurity of medical devices. Public comments are open until May 13, 2024, following which the FDA will review and incorporate feedback into the final guidance document.
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.
