FDA Class II

FDA Class II devices are medical products that carry a moderate level of risk and require special regulations to ensure safety and effectiveness. These devices typically need to undergo a review process called premarket notification (510(k)), where manufacturers demonstrate that their product is substantially equivalent to a device already on the market. Examples include pregnancy test kits and blood pressure monitors. The classification helps regulators monitor and control the safety standards, ensuring that these devices perform their intended function reliably without posing significant risk to users.