Medical Device Regulation What is the FDA classification of sterilization packaging? March 7, 2026 by Myaya | Leave a Comment The FDA classifies sterilization packaging based on its intended use and the sterilization method it will be used with. The primary classifications are Class I medical devices for general sterilization wrap and Class II medical devices for sterile barrier systems. These classifications dictate the regulatory requirements for manufacturing, testing, and marketing. Understanding FDA Classification for […] Read more ยป