FDA Product Code MED: Sterilant, Medical Devices

FDA product code MED covers medical device sterilants used for the chemical sterilization of heat-sensitive instruments and equipment.

These liquid sterilant solutions — typically glutaraldehyde, peracetic acid, or hydrogen peroxide-based — achieve high-level disinfection or sterilization of endoscopes, surgical instruments, and other devices that cannot withstand steam sterilization temperatures.

MED devices are Class II medical devices, regulated under 21 CFR 880.6885 and reviewed by the FDA General Hospital panel.

Leading manufacturers include STERIS Corporation, Advanced Sterilization Products and Metrex Research Corp..