Premarket Approval

The FDA regulates medical devices on a three-tier, risk-based approach. Class III medical devices, or high-risk medical devices, are typically subject to the most stringent regulatory requirements, including the submission of a premarket approval application (“PMA”). Contrasted with the premarket notification process, the PMA (premarket approval) process is more rigorous because it requires a device sponsor to demonstrate that its device is safe and effective for its intended use, based on scientific evidence. Accordingly, these submissions are typically much lengthier and more detailed than the documentation needed for FDA clearance. However, once a device is the subject of an approved PMA, the device sponsor may refer to the device as “FDA Approved.”