There’s a myriad of tests medical device manufacturers need to be prepared to conduct on their creations in order to pass regulation requirements before they are released to the marketplace. None more important than the Cytotoxicity, Sensitization, and Irritation tests—the Big Three as we call them.
They are the Big Three because they must be conducted on every device before they can be submitted to the Food & Drug Administration (FDA). There is no way you can get around doing the three tests. Other tests may or may not need to be conducted.
By understanding these three tests, you can be better prepared for submission to the FDA and better prepared to write justifications when the tests indicate a failure.
Presenter: Thor Rollins