Consumer Warranty Law: 1.6.2.1.1 The review system for medical devices
The Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act set up a system for Food and Drug Administration (FDA) review of medical devices.215 The statute categorizes medical devices as Class III, Class II, or Class I, depending on the risk they pose to consumers. For Class III devices, the ones that pose the greatest risk, the FDA requires pre-market approval, its most rigorous review.