In September 2023, the FDA released a new revision to its guidance document on the use of ISO 10993-1, which focuses on the evaluation and testing of medical devices within a risk management process. The first question to ask when a new revision is released is, “What changed?” Once that question is answered, a follow up question is, “How does that impact my device and/or submission?”
This 60-minute Webinar will review the changes to the FDA’s guidance document — including a look at the information provided in the FDA’s explanatory webinar given in October 2023 — as well as how to assess the revision’s impact on different situations. Speakers also will review some of the unchanged information to highlight lessons learned on the practical application of the guidance document.
- Changes found in the new revision of the FDA guidance document
- How to assess the impact to individual situations
- Lessons learned through practical application of the document
An audience Q&A session will follow the technical presentation.
Audrey Turley, Director and Biocompatibility Expert, Expert Advisory Services, Nelson Labs
Audrey Turley is the Director of Expert Advisory Services at Nelson labs, where she currently leads the team of subject matter expert consultants. She has more than 25 years of experience working in research, laboratory, and test design functions in the medical device industry. Audrey is a registered biologist and a biocompatibility expert with 15 years’ experience in the lab performing all in vitro tests offered at Nelson Labs, which include cytotoxicity, hemolysis, and genotoxicity. She was responsible for the development of the in vitro mammalian chromosome aberration assay at Nelson Labs and was on the team that developed and validated the in vitro irritation assay for medical devices. Audrey is an active committee member of several working groups within the Association for the Advancement of Medical Instrumentation and at the International Standards Organization level.
Helin Räägel, Ph.D., Senior Biocompatibility Expert, Expert Advisory Services, Nelson Labs
Dr. Helin Räägel is a Senior Biocompatibility Expert and the Scientific Thought Leader within the Expert Advisory Services division of Nelson Labs. Her work focuses on assisting medical device manufacturers to find creative solutions in their approach to biological evaluations targeted for regulatory submissions around the world. Helin is an active member of ASTM and ISO 10993 working groups. She is passionate about the intersection of science and biocompatibility and frequently contributes to the global conversation around the risk-based approach to medical device biocompatibility in the form of published articles and webinars. Helin holds a PhD in molecular cell biology. Her successful academic career was highlighted by globally competitive research awards including an Alexander von Humboldt Fellowship in Germany and a Marie Curie Fellowship.
Amanda Hosey, Editor, SAE Media Group