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510(k) Process / 510(k) Clinical Testing

Much of the innovation that occurs in the medical technology realm is the result of incremental progress. Based on feedback from physicians or patients, for example, a company may decide to modify an existing product for ease of use or greater comfort. Advances in materials science or other disciplines may prompt a company to change a product to increase durability or longevity.

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.”

Risk and Medtech

No medical intervention -- whether it involves a surgical procedure, a hospital stay, prescription pharmaceutical, medical device or OTC drug – will ever be entirely risk free. And despite the best efforts of industry and FDA, no amount of testing or review will be able to anticipate and prevent every adverse event or negative consequence. “That’s not the world we live in,” says Dr. Susan Alpert.

Patient Information

Undergoing any medical procedure – especially one involving surgery or implantation of a medical device – can be a worrisome and stressful experience for patients. That is why it is so important for patients to have a frank and honest discussion with their physicians before deciding on any medical intervention.

Industry-FDA Interactions

Medical technology manufacturers and FDA share a common goal: To ensure patients have timely, access safe and effective medical devices and diagnostics. To achieve that shared goal, manufacturers and FDA must have clear, well-understood regulatory requirements and open lines of communication.

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