Header Artwork
Header Artwork

ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Shifting Requirements Within the FDA: Expectations in Chemistry Study Design

Published Date: August 25, 2020

Expectations of the FDA regarding the design of chemistry studies in support of medical device toxicology has been shifting rapidly. New expectations have primarily been communicated to laboratories through submission feedback, and pre-submission meetings, as the FDA has not yet released guidance on application of ISO 10993-18. This presentation focuses on how chemistry study design has changed over the last 12 months in response to FDA received from the FDA.

Key points in this webinar:

  • Expected sensitivity of analysis, the analytical evaluation threshold (AET), and appropriate inputs in AET derivation
  • Exhaustive extractions, comparison of NVR to analytical results
  • Expectations for evidence of method suitability, standards and calibrations
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...

Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

Complete the following information to access the webinar