FDA regulatory requirements Most of the complex medical device instruments require premarket notification [510(k) or even a PMA (premarket approval) 510(k) and PMA Guidance Documents include requirements for reprocessing instructions for the user: Detailed cleaning instructions, including disassembly. Detailed disinfection & sterilization instructions with specific sterilization parameters. Expected end of life & how this can Read more about Cleaning validation and Labelling Requirements for reusable medical devices[…]