Cleared vs. Approved: What Does the FDA Mean?
Ask a medical device engineer if their product is FDA “approved,” and you might see them twitch. That’s because, in FDA-land, ‘approved’ and ‘cleared’ aren’t synonymous. They’re different regulatory universes. Mix them up in a submission or investor meeting, and you’re not just in for some awkward course corrections, but also potential delays and misunderstandings […]
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