Pathway

FDA’s STeP Program

The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.1 This particular pathway is reserved for devices with unique and other-wise unavailable treatments to serious conditions, but what...

11 January, 2021 / 0 Comments

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 medical technologies. Part of this streamlining is enhancing the Safety and Performance Based Pathway, which is an alternative route to traditional...

21 December, 2020 / 0 Comments

Pathway

FDA’s STeP Program

Advancements in the FDA’s Safety and Performance Based Pathway

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