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Listen "Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product"
Episode Synopsis
Have you ever struggled to understand the regulatory difference between a product, an accessory and a component?
Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component?
A group of medical device manufacturers asked those very same questions during a presentation I gave in the fall of 2020.
The answers apply to more than just ventilators, so there is something in this video for just about everyone.
If you want to view the video version with the slide deck, check it out on my YouTube channel: https://youtu.be/e-UTXSFwHaw
Enjoy!
Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component?
A group of medical device manufacturers asked those very same questions during a presentation I gave in the fall of 2020.
The answers apply to more than just ventilators, so there is something in this video for just about everyone.
If you want to view the video version with the slide deck, check it out on my YouTube channel: https://youtu.be/e-UTXSFwHaw
Enjoy!
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