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The Big Three: Cytotoxicity, Sensitization & Irritation Testing

Published Date: June 7, 2021

Of all the tests manufacturers need to be prepared to conduct on their medical devices, none are more important than the Big Three—Cytotoxicity, Sensitization, and Irritation tests. Manufacturers need to understand these three tests because they must be conducted on every device before they can be submitted to the Food and Drug Administration (FDA). There is no way you can get around these tests without strong and accurate justification.

Understanding the Big Three, manufacturers can be better prepared for submission to the FDA and better prepared to write justifications when the tests indicate a failure.

This talk will review the current status of these big 3 tests, what the future holds, and how to problem-solve.

By attending this webinar, attendees will learn:

  • An overview of the big 3 tests
  • Discussion regarding the updated 10993-1 2018 and the possibility of a big 5
  • Current regulatory trends for these tests and what the standard committees are working on.

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