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Glossary Term
Class II Medical Devices (FDA)
Definition
Class II Medical Devices are devices that present a moderate to high risk to patient safety and require additional regulatory controls beyond general controls to ensure safety and effectiveness. Examples include powered wheelchairs, infusion pumps, and surgical drapes. These devices typically require premarket notification through the 510(k) process or, in some cases, may qualify for exemptions.
Relevance to the MedTech Industry
Class II devices address more complex healthcare needs compared to Class I devices, requiring additional testing, controls, and oversight. This ensures their safety and performance in clinical environments while allowing for innovation and market entry.
Additional Information & Related Terms
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