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.

FDA’s regulatory approach to medical technology recognizes this and provides an efficient pathway for low- and moderate-risk devices and diagnostics to get on the market while still ensuring their safety and effectiveness. Unfortunately, this premarket notification pathway – commonly known as “510(k)” - is “perhaps the most misunderstood program in the world,” according to Dr. Susan Alpert.

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