One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing the...
Pathway
FDA’s STeP Program
The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of...
Advancements in the FDA’s Safety and Performance Based Pathway
One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient access to new...
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