"A medical device is, simply defined, any item used to diagnose, treat, or prevent disease, injury, or any other condition that is not a drug, biologic, or food. The official United States (U.S.) definition of the term ‘device’ can be found in the Federal Food Drug & Cosmetic Act (1998) enforced by the U.S. Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services.
Medical devices range from items as simple as tongue depressors to more complex devices, such as ventilators. They represent some of the most innovative technologies developed in recent years. Yet regardless of how novel a device may be, the public expects, and the Food and Drug Administration requires that medical devices be safe, effective, and manufactured in accordance with current manufacturing practices."
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