You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? 

Breathe - and listen in as Michelle walks you through the options.

You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? Breathe - and listen in as Michelle walks you through the options.

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Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices

Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices

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