Medical devices are assigned to one of three classifications depending on the level of oversight necessary to ensure the safety and effectiveness of the device. A Class 1 device (e.g. non-powered breast pumps, tongue depressors, etc.) poses little risk of harm to the user, and so they are only subject to minimal controls and most are exempt from premarket approval or notification requirements. Devices that are considered moderate risk are Class 2, and the manufacturer must demonstrate that it is “substantially equivalent” to a legally marketed device that does not require premarket approval. Class 3 devices are high-risk such as mechanical heart valves. The manufacturer must prove by way of scientific evidence, including clinical trials, that the device is safe and effective for its intended use before it can enter the market.
