All You Need to Know About FDA Medical Device Classifications
Learn about FDA Medical Device Classifications in 30 seconds!
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Example: dental floss
Class I devices are deemed to be low risk (they present minimal potential for harm to the user) and are therefore subject to the least regulatory controls. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
Example: motorized wheelchair
Class II devices are higher risk devices and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. 43% of medical devices fall under this category.
Class III devices are the highest risk devices and are subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. 10% of medical devices fall under this category.