Class II medical devices are more complicated than Class I devices and present a higher category of risk because they are more likely to come into sustained contact with a patient. This can include devices which come into contact with a patient's cardiovascular system or internal organs, and diagnostic tools.
The FDA defines Class II devices as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”
Bringing Class II Medical Devices to Market
The majority of Class II devices are FDA approved for the market through the Premarket Notification, or 510(k) process.
Class II devices are subject to the same General Controls mentioned above, but the FDA defines them as being “devices for which general controls are insufficient to provide reasonable assurance of the
safety and effectiveness of the device.” For that reason, Class II devices are also subject to Special Controls. These regulations depend on the device and may include special labeling requirements, patient registries, and performance standards.
Most Class II devices come to market using the Premarket Notification (510k) process. The 510(k) is a complex application to the FDA, which demonstrates that a device is safe and effective by demonstrating that the device is equivalent to another device which is on the market.
This process involves showing "substantial equivalence" to another device which is known in FDA parlance as "the predicate." This doesn't mean the devices need to be identical, but they require significant similarities in use, design, materials, labeling, standards, and other characteristics.
The FDA released an exemption list in early 2018 which exempts over 800 generic Class I and II medical devices from the 510(k) process. If you have a generic Class II medical device, you can discover whether it is exempt from a 510(k) filing by searching the FDA Product Classification database.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
