When you think “510k” but FDA says “DeNovo” with Spencer Jones

Medical Device made Easy Podcast · Aug 9, 2022

This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the product to be registered with the 510k Regulatory Pathway but the FDA did not agree and said that they should go through DeNovo. So Spencer Jones who founded the company will tell us how they have done that and he will also give some tips on how he would have done it today if he had to restart again. So benefit from his journey to learn how you should do it.

Who is Spencer Jones?

Spencer worked for three years in direct patient care as…