FDA Attorney Services - Premarket Approval Services

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.

Do you have any questions about your device or an FDA regulatory attorney can help you with the premarket approval process? Please contact us today at (305) 507-9843 for the best FDA attorney services. You can also visit us online for more details.