FDA issued a draft guidance on August 22 detailing the types of modifications it considers suitable for inclusion in a Predetermined Change Control Plan (PCCP) and the information sponsors should include in their premarket approval (PMA), de novo, or 510(k) submissions to support their proposed PCCP.
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.
