Regulation of Medtech vs. Drugs

Comparing medical devices and pharmaceuticals is like comparing apples and oranges. Drugs interact with a patient metabolically, immunologically, or pharmacologically. As Susan Alpert explains, “Pharmaceuticals are discovered: you don’t know much about them until you start using them and start evaluating them in actual patients.”

Medical devices are developed and delivered in a completely different way. Susan says, “Medtech is designed to take care of a specific problem, a specific issue, a specific type of patient. The manufacturer works with the clinical community and designs the product, picks the materials, picks the design, and tests it extensively.”

Susan also notes that medical technologies constantly evolve through small, incremental improvements, while pharmaceuticals are stable, unchanging molecular entities.

These differences considered, it makes sense that drugs and medical devices are regulated in different ways.

Watch as Susan explains the technology-tailored regulatory pathway for medical devices in the video below. Learn more about Premarket Requirements.

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