FDA 101: Understanding the OTHER Regulatory Giant

RAQA Today
08/09/2025 23 min

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Episode Synopsis

Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer, we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de novos, and PMAs. Learn how the FDA oversees everything from tongue depressors to pacemakers and why regulatory strategy can make or break your product’s success.Watch the video version on YouTube: https://youtu.be/nw9f7r5aWqE

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