Overview of FDA Medical Device Classification System

The FDA divides medical devices into Class I, II, and III according to the risk posed
by the device. Regulatory controls increase from Class I to Class III.

I

Class I devices are deemed to be low risk and are therefore subject to the least amount of regulatory control. Class I devices are often non-powered devices that use known technologies.
Example: Dental floss is classified as a Class I device.

II

Class II devices are medium risk devices and require greater regulatory control to provide a reasonable assurance of the device’s safety and effectiveness. Class II devices can typically be powered, implanted, or use an unknown technology, but usually not all three.
Example: A blood pressure cuff is classified as a Class II device.

III

Class III devices generally pose the highest level of risk to patients and are therefore subject to the highest level of regulatory control. These devices typically involve risky new technologies which are life-supporting, dangerous, and/or implanted.
Example: Replacement heart valves are classified as a Class III device.

Be prepared for the unique regulatory controls required during design, development, manufacture and post market support.

Get in touch with a StarFish regulatory specialist today.

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