The release of ISO 10993-1 in 2018 marked a significant shift in the biocompatibility evaluation of medical devices, emphasizing a risk-based approach and the 3Rs of animal testing—reduction, replacement, and refinement. In 2021, ISO 10993-23 introduced a revolutionary change, promoting the use of an in vitro irritation test as a preferred alternative to the traditional rabbit irritation test.
This presentation will explore the current status of in vitro testing within the medical device biocompatibility industry. Attendees will gain insights into how these new standards are being implemented and the implications for biocompatibility testing processes. The discussion will include an overview of the FDA’s stance on in vitro testing, highlighting regulatory perspectives and guidelines that are shaping the industry.
Participants will learn about the numerous benefits of in vitro alternatives, which offer more ethical, efficient, and potentially cost-effective testing methods compared to traditional animal testing. In vitro tests not only align with the ethical principles of the 3Rs but also provide reliable and reproducible results that are crucial for ensuring the safety and efficacy of medical devices.
The presentation will also look ahead to the future of animal testing in biocompatibility evaluations. By examining current trends and emerging technologies, attendees will understand the ongoing shift towards in vitro and other non-animal testing methods. This forward-looking perspective will help industry professionals prepare for future regulatory changes and adapt their testing strategies accordingly.
By attending this presentation, professionals involved in the development, testing, and regulatory compliance of medical devices will acquire valuable knowledge about the latest biocompatibility standards and the evolving landscape of in vitro testing. This understanding is essential for aligning with regulatory expectations, enhancing testing processes, and contributing to the ethical advancement of medical device evaluations.