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Strategic Use of Predicate Controls in Biocompatibility Evaluations
March 16, 2021 @ 11:00 am - 12:00 pm
Biocompatibility is no longer a checkbox approach and as the technology behind devices becomes more advanced, so too do the evaluations used to assess medical devices. The use of predicate controls in the biological evaluation of medical devices including biological evaluation plans, risk assessments and testing can help frame the context of a new device. In testing, the use of predicate controls in traditional evaluations including implantation and hemocompatibility, but also additional ones such as irritation and toxicity, can help normalize and clarify results to best understand the difference between positive and adverse results.