Class “II” Devices
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.
Class II devices are defined as being “moderate to high risk.” Devices in Class II include CT scanners, pregnancy test kits, and even the Apple Watch. This can include devices that come into contact with a patient’s cardiovascular system or internal organs, as well as diagnostic tools.
These are devices that have more impact on a user’s life than devices in Class I. Class II devices are typically ones that someone is likely to rely on for health decisions, and that have a more complicated or technological design. Other examples of Class II devices include catheters, blood pressure cuffs, syringes, blood transfusion kits, contact lenses, surgical gloves, and absorbable sutures.
Life-sustaining devices, such as pacemakers and ventilators are typically in Class III and are subject to greater requirements and a longer approval process.
Devices are categorized as Class II when the FDA has concluded that general controls are not stringent enough to ensure public safety. There is a higher need for assurances of safety and effectiveness with these devices. For these reasons, Class II has higher controls.
General Controls, which are used for Class I devices, are not sufficient for Class II devices. Rather, special controls are called for, so Class II devices have special, heightened regulatory requirements. The Special Controls can vary by device, and include:
- Performance standards
- Post-market surveillance
- Patient registries
- Special labeling requirements
- Premarket data requirements
Most Class II devices, though not all, do require a 510(k) pre-market notification. Class II devices can, however, still be approved rather quickly, in as few as 90 days. For a device to be approved quickly, there must be a device already on the market that is substantially similar to the one being submitted. If such a device exists, the FDA is likely to move much more quickly to approve a subsequent, similar device.
For example, the very first hip replacement implants were made from titanium and plastic and required premarket approval. Devices that came later, using different materials or slightly different designs, were able to use the 510(k) path already established by the first generation of hip implants.
The FDA often reassesses the classifications, requirements, and exemptions of medical devices. Ever cognizant of the public desire to speed devices to market, but also aware of the need to maintain high safety and efficacy standards, each year the FDA changes the classifications of some devices and allows new exemptions for others. This is why it’s important to research the most current classifications and exemptions instead of assuming the previous ones still apply.
