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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Recent FDA biocompatibility feedback from 510k submissions

Published Date: November 10, 2020

Submitting for an approval for a medical device through the FDA can be a stressful and anxious time. It is important to understand the most recent recommendations from the agency. Too often these recommendations are given through feedback from the submission process itself, making a proactive approach difficult. In this presentation we will review recent FDA suggestions from real 510k submissions. These suggestions will touch on all aspects of the ISO 10993 standard series from cytotoxicity, sample preparation, E&L, toxicology, and more.

Thor Rollins

Thor Rollins

BS, RM (NRCM)
Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

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