FDA approval for IVDs requires evidence of how well test predicts the presence, absence, or risk of a specific condition. This is shown through analytical validity and clinical validity. To obtain payer coverage and provider adoption also requires evidence of clinical utility. Often, these are developed sequentially instead of simultaneously adding time and expense to developing clinical evidence for new IVD tests.
MDIC’s IVD Clinical Evidence project is focused on the creation of an evidence whitepaper that IVD manufacturers can use to make decisions on how to develop credible evidence of analytical and clinical validity, as well as clinical utility.
This project helps patients gain expedited access to medical device technologies. Industry stakeholders can also benefit by seeing a decrease in time when developing clinical evidence, lower costs for clinical evidence generation, and decreased time for coverage decisions. This project support’s CDRH’s mission to maintain US leadership in medical device innovation and improved data quality for regulatory submissions.