Navigating FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry – ASK OUR EXPERT
In this insightful interview, Dr. Tino Otte, an Extractables and Leachables Expert and Director of Business Development at Intertek Switzerland, discusses the FDA Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry.
We address key questions and hot topics, including:
- You'll learn what specific areas the FDA Draft Guidance covers and its primary aim.
- Discover what chemical characterization for the evaluation of medical devices entails.
- Understand the recommended study approach in this draft guidance.
- Find out the FDA’s recommendations for extraction conditions and solvents, and how to justify deviations.
- Explore the key steps involved in sample preparation, analytical testing, and the evaluation of results.
- Learn the key principles and requirements for applying the Analytical Evaluation Threshold (AET), and more!
Download our expert commentary on FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry by filling out the form below:
Switzerland Analytical Laboratory
Intertek's Swiss analytical laboratory provides advanced lab testing to GLP/GMP standards for the pharmaceutical and medical device sectors