21 min listen
Submitting a 510(k) using FDA's Safety and Performance Based Pathway
FromGlobal Medical Device Podcast powered by Greenlight Guru
Submitting a 510(k) using FDA's Safety and Performance Based Pathway
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
45 minutes
Released:
Sep 2, 2020
Format:
Podcast episode
Description
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.
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.
Released:
Sep 2, 2020
Format:
Podcast episode
Titles in the series (100)
The Difference Between Intended Use and Indications of Use with Mike Drues: It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can des... by Global Medical Device Podcast powered by Greenlight Guru