How do clinical trials work for a medical device in the USA?

[@Nashi43]

Thank you for the video! You have a really effective way of communicating your ideas.

[@MedicalDeviceAcademy]

Thank you for the positive feedback. Suggestions for future topics are always welcome.

[@lindseyjardine8357]

Hey! I was wondering if you could talk about how the breakthrough process work for a PMA.

[@MedicalDeviceAcademy]

Next Friday, October 6, we will have a live-streaming video on the breakthrough device designation and I will add information about PMAs.

[@jesseniacastillo6181]

Thank you, Rob, this video was very helpful! During your discussion on statistical comparison, you mentioned superior, non-inferior and equivalent analysis. Can you describe how a superior analysis can be used if US submissions are based on substantial equivalence? Thanks!

[@MedicalDeviceAcademy]

Superiority is usually not used for 510(k) submissions. Typically it would only be used for a De Novo, HDE, or PMA.

[@thebig_steel]

Dude, amazing presentation. Thanks additionally for dropping that discount 14155, I was worried the only way to get a hold of it was to spend hundreds.

[@MedicalDeviceAcademy]

We all like to save a dollar, and that tip was originally shared by Leo Eisner ~10 years ago.