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

Published: Aug. 9, 2022, midnight

b'What would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones will tell us what he learned during this process. The post When you think \\u201c510k\\u201d but FDA says \\u201cDeNovo\\u201d with Spencer Jones first appeared on Medical Device made Easy Podcast. The post When you think “510k” but FDA says “DeNovo” with Spencer Jones appeared first on Medical Device made Easy Podcast. Monir El Azzouzi'