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FDA 101: Understanding the OTHER Regulatory Giant

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Manage episode 505196609 series 2446473
Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by 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://podcastplayer.com/legal.

Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer, we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de novos, and PMAs. Learn how the FDA oversees everything from tongue depressors to pacemakers and why regulatory strategy can make or break your product’s success.

  continue reading

55 episodes

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iconShare
 
Manage episode 505196609 series 2446473
Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by 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://podcastplayer.com/legal.

Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer, we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de novos, and PMAs. Learn how the FDA oversees everything from tongue depressors to pacemakers and why regulatory strategy can make or break your product’s success.

  continue reading

55 episodes

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