Credibility assessment process in regulatory submissions: a case study

Dr. Hariharan details a case study where FDA worked closely with a medical device company to apply the credibility assessment principles of the ASME V&V 40 standard in a regulatory submission. We will share the outcomes from the validation study, credibility assessment and its impact on the regulatory decision. Further, the presentation will also discuss the benefits of V&V 40 in the regulatory process and the potential role of FDA scientists in assisting device industry to apply the risk-informed credibility assessment framework to their computational models.