Long Time Passing: Where Have All the De Novo Decision Summaries Gone?
FDA Law
AUGUST 18, 2024
The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. Each of these De Novos can represent a clinical advance. De Novos now play an important role in product advancement.
69 
Let's personalize your content