FDA Feedback from Recent Biocompatibility Submissions
January 20 @ 6:00 pm - 8:00 pm UTC-7$10 – $15
Thor S. Rollins
Director, Toxicology and E&L Consulting
Nelson Laboratories, LLC
Nelson Labs has a great deal of experience performing biocompatibility and extractable and leachable (E&L) studies for regulatory submissions – including the US FDA. With this experience, Nelson Labs has followed FDA feedback trends on recent submissions and developed specific procedures to address this feedback.
In this presentation, Thor will cover the recent FDA biocompatibility and E&L feedback and concerns and will discuss approaches to address these concerns before the submission process.
Thor Rollins is a certified microbiologist who specializes in the selection and execution of in vitro and in vivo biocompatibility tests. Currently he is the Director, Toxicology and E&L Consulting at Nelson Laboratories, LLC. He actively speaks on biocompatibility related topics through external seminars, webinars, conferences, and trade shows. Thor has published multiple peer-reviewed articles and white papers regarding the proper testing of medical devices.
Thor is a participating member of all AAMI (Association for Advancement of Medical Instrumentation) TC 194 and ISO 10993 committees. He plays an active role with the FDA and other regulatory committees in developing standards concerning biocompatibility methods; he is also a voting member regarding changes to those standards. As one of a select group of experts in the industry, Thor’s participation on these committees offers him unique insight into industry changes which he uses to help prepare clients for changes in testing.