When you think “510k” but FDA says “DeNovo” with Spencer Jones - podcast episode cover

When you think “510k” but FDA says “DeNovo” with Spencer Jones

Aug 09, 2022Transcript available on Metacast
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Episode description

What would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones will tell us what he learned during this process.

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