Table 3.

FDA classification of medical devices

Category	Examples	Approval requirements
Class I (Low risk)	Examination gloves Compression device Bone tamp	Registration only
Class II (Moderate risk)	Infusion pumps ORIF plates Intramedullary nails	510(k) notification
Class III (High risk)	Heart valves Total disc replacements Mobile-bearing TKA systems	Premarket approval application

Adapted from The Medicare Payment Advisory Commission (MedPAC). An overview of the medical device industry. Report to the Congress: Medicare and the Health Care Delivery System. Washington, D.C.: 2017; with permission.