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

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Manage episode 337163852 series 2446473
Content provided by RAQA Today and Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RAQA Today and Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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.
  continue reading

44 episodes

Artwork
iconShare
 
Manage episode 337163852 series 2446473
Content provided by RAQA Today and Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RAQA Today and Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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.
  continue reading

44 episodes

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