PMA vs 510K: Understanding the Differences in Premarket Approval for Medical Devices

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When it comes to getting a medical device approved for market, there are two main routes manufacturers can take: premarket approval (PMA) or premarket notification (510(k)). Both are regulated by the Food and Drug Administration (FDA), but they have different requirements and different levels of scrutiny. In this article, we will explain the key differences […]

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