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.
