From EFS to Market: Biocompatibility Considerations that Streamline Development

Explore the essentials of biocompatibility assessment for medical devices in early feasibility studies, with a focus on FDA expectations, ISO 10993-1 guidance, and risk management strategies. Dive into practical examples, including detailed biocompatibility evaluation plans for devices with blood contact, and learn how to leverage scientific justifications, prior testing, and literature to address endpoints like genotoxicity, chronic toxicity, and carcinogenicity. Discover how device materials, manufacturing processes, and clinical mitigation strategies influence acceptable uncertainty at each development stage, from EFS to marketing. Gain insights into reporting requirements, leveraging prior data, and best practices for material and supplier selection to streamline device development while maintaining patient safety.