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Podcasts

Podcasts

New FDA Draft Guidance for Chemical Analysis

In this podcast our host Brandon Miller from Regulatory Compliance Associates is joined by Raymond Colton, Director of E&L at Nelson Labs, and Sarah Campbell, PhD and board-certified toxicologist at Nelson Labs, to discuss the recent draft of FDA guidance document “Chemical Analysis for Biocompatibility Assessment of Medical Devices.” Our experts discuss why this guidance is important, its potential impacts to medical device manufacturers, and some of the best practices that Nelson Labs is already implementing to ensure a smooth transition once the guidance document is published. Also discussed are changes to current approaches to chemical characterization and leeway that could potentially be given depending on the product.

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Raymond Colton

Raymond Colton

E&L Expert

Raymond Colton is a long-time industry expert in extractables and leachables (E&L). He has a great depth of industry experience and founded an E&L testing laboratory in 2001, which he sold in 2018.  For over two decades he has been instrumental in advancing the science of E&L testing by participating in industry forums, publishing papers,...

Sarah Campbell, PhD

Sarah Campbell, PhD

DABT
Toxicology Expert

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas...