Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

0 0 hace 6 meses
What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the Safety and Performance Based Pathway that's designated for certain types of medical devices only and what eligible companies should consider when using this pathway for submitting a 510(k) to receive FDA clearance.

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