The US FDA regulates all medical devices marketed in the US, which are grouped into three broad classes. Any medical device approved by the FDA is classified as either Class I, II, or III depending on the device's risk, invasiveness, and impact on the patient's overall health. But where are the lines drawn between each of these three classes, and why?
The US FDA's classification guidelines can be highly confusing to medical device manufacturers with limited exposure to the system. There is an enormous difference in the optimal path to market for manufacturers depending on how your device is grouped. Class I devices are subject to far fewer regulatory requirements than Class II or III devices.
By understanding the differences in the FDA medical device classes, you can understand how your device will be grouped. With this knowledge in hand, medical device manufacturers in the premarket stages can better prepare and allocate the resources needed for regulatory approval.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
