Does a Class I device need the same insurance as a Class III device?

No - device class is a proxy for risk, and it drives the sizing of the program. FDA classifies devices by the level of control needed to assure safety and effectiveness: Class I (low risk, general controls), Class II (moderate risk, special controls, usually 510(k)), and Class III (high risk, usually life-sustaining or implantable, requiring premarket approval). The higher the class and the more severe a failure, the higher the products and umbrella limits.

A Class I accessory maker faces lower bodily-injury severity and can often start with a modest products tower, while a Class III implantable-device maker faces high-severity, potentially catastrophic claims and carries materially higher limits, closer underwriting, and specialty-market placement. Class II devices sit in between and are the largest segment.

Classification also interacts with the contracts: hospital and GPO agreements for higher-risk devices tend to require higher combined limits. So while every device manufacturer buys the same categories of coverage, the class shapes the limits, the market, and the price.