Table 1.

FDA Medical Device Classification and Approval

Device class	Risk	Application Required for FDA Approval
Class I:
Exempt	Low	None, but must comply with general controls
Non‐exempt	Low	510(k) submission
Class II
Exempt	Moderate	None, but must comply with general and special controls
Non‐exempt	Moderate	510(k) submission
Class III	High	Premarket Approval Application (PMA)

FDA, US Food and Drug Administration.