Table 2.

Risk-Based Approach to FDA Regulation of Medical Devices^70,71

Classes of “Medical Devices”	Definition	Risk Category	General Requirements
Class I	“Devices for which the general controls of the Act are sufficient to provide reasonable assurance of their safety and effectiveness. They typically present minimal potential for harm to the user and the person being tested….”	Low	General controls, e.g., registration and listing, labeling, adverse reporting, and good manufacturing practices
Class II	“Devices for which general controls alone are insufficient to provide reasonable assurance of their safety and effectiveness and for which establishment of special controls can provide such assurances…”	Moderate	General and special controls, e.g., registration and listing, labeling, adverse reporting, and good manufacturing practices as well as premarket notification, special labeling, mandatory performance standards, risk-mitigation measures, and postmarket monitoring
Class III	“Devices for which insufficient information exists to provide reasonable assurance of safety and effectiveness through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury…”	High	General controls and premarket approval

Device classification depends on “intended use” and “indications for use.”