Step 4: FDA Device Review
If medical device developers have enough information on a device’s safety and effectiveness, they can file an application to market the device to the public. The type of application they file depends on the device’s class.
- Humanitarian Device Exemption
Humanitarian Use Devices benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 people. Before they can market a Humanitarian Use Device, developers must submit a human device exemption and must demonstrate that there are no similar, legally approved devices on the market and that there is no other way to bring a Humanitarian Use Device to market.
- Premarket Notification or 510(k)–Class 1, 2 and 3 Devices
Premarket Notification, also known as a 510(k), indicates that the Class 2 medical device is similar to others on the market. To support the claim, the developer compares the new device to one or more similar, legally marketed devices.
- Premarket Approval Application–Class 3 Devices
Premarket Approval applications must be submitted for Class 3 devices and must include data from all nonclinical studies and clinical studies. During the approval process, FDA will inspect the manufacturing laboratories and facilities where the device will be made to check for good manufacturing practices.
If appropriate, FDA will consult an Advisory Committee at a public meeting. FDA Advisory Committees consist of groups of experts who provide FDA with independent advice on an issue. The panels recommend whether a product should be approved or not.
After the Advisory Committee meets, FDA decides whether the device is approvable or not approvable, or request additional information. By law, FDA must publish its decision with all supporting evidence in the Federal Register.