FDA classifies medical devices into three categories based on the risk level and regulatory controls needed to provide reasonable assurance of safety and effectiveness. Classification determines the type of premarket submission required.
Class I
Low Risk
~47% devices
Class II
Moderate Risk
~43% devices
Class III
High Risk
~10% devices
Determine FDA device class and regulatory pathway
Low risk devices subject to general controls only.
Moderate risk devices requiring special controls.
High risk devices requiring premarket approval.
Important Disclaimer
This tool provides preliminary guidance only. Final device classification is determined by FDA based on the specific characteristics and intended use of your device. Device classification can be complex and may require consultation with regulatory professionals. Always verify classification using FDA's official databases and guidance documents.
Demonstrate that your device is substantially equivalent to a legally marketed predicate device. Most common pathway for Class II devices.
For novel devices with no predicate that are low-to-moderate risk. Creates a new classification regulation that can serve as a predicate for future devices.
Most stringent pathway for Class III devices. Requires clinical evidence demonstrating reasonable assurance of safety and effectiveness.
Many Class I and some Class II devices are exempt from premarket notification. Still subject to general controls and establishment registration.