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Resource CenterWhat Does FDA Consider a Combination Product? Accordingly, the U.S. Food and Drug Administration (FDA) defines a combination product that is composed of any combination of a drug and a device; a biological product and a device; a drug, device, and a...
Resource CenterDigital health technology has revolutionized the healthcare field, affording new patient care techniques and increased patient control. The FDA’s new Digital Health Center of Excellence establishes digital health as one of the agency’s central focuses...
Resource CenterMedical devices inevitably possess risk, so manufacturers should continue to evaluate their products after they reach the market. By creating an effective post-market surveillance plan, you can increase user safety and satisfaction.What is post-market...