Globiox Blog Almost There: Safety and Performance Pathway Option for 510(k) Submissions

On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the new device manufacturer would have to…Read More