Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices
Released Tuesday, 9th August 2022
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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
Tuesday, 9th August 2022
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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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