Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the Big Three—Cytotoxicity, Sensitization, and Irritation tests. These tests are fundamental to ensuring the biocompatibility of medical devices and are mandatory for every device submission to the Food and Drug Administration (FDA). Manufacturers cannot bypass these tests without providing strong and accurate justifications, making a thorough understanding of them essential.
Cytotoxicity testing assesses the potential of a device to cause cell damage, which is crucial for identifying any toxic effects the device materials might have on the body. Sensitization tests evaluate whether a device might cause an allergic reaction, a key concern for patient safety. Irritation tests determine if the device could cause irritation when in contact with skin or mucosal tissues. These tests collectively ensure that medical devices are safe for patient use.
This webinar will delve into the current status of these Big Three tests, providing attendees with a comprehensive overview of their importance and execution. We will discuss the updated ISO 10993-1:2018 standard, which outlines the biological evaluation of medical devices and introduces the potential for expanding the required tests to a “Big Five,” including additional evaluations for systemic toxicity and material-mediated pyrogenicity.
Participants will also learn about current regulatory trends and what standard committees are working on to keep the testing procedures up-to-date with the latest scientific and regulatory developments. This insight will help manufacturers stay ahead of regulatory changes and ensure their devices meet all necessary safety standards.
By attending this webinar, manufacturers will be better equipped to conduct these essential tests and interpret their results. They will learn how to prepare justifications when test results indicate potential issues, ensuring a smoother FDA submission process. This proactive approach not only enhances regulatory compliance but also improves overall product safety and efficacy.