IVD Clinical Evidence

Needs and Opportunities (Problem/Challenge):

  • 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
    • 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.

Vision (Solutions):

To create 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.

Value to Stakeholders:

  • Patients: Expedited access to medical device technologies
  • Industry:
    • Decrease time when developing clinical evidence
    • Lower costs for clinical evidence generation
    • Decrease time for coverage decisions
  • FDA:
    • Support CDRH’s mission to maintain US leadership in medical device innovation and expedited patient access to new technologies
    • Improved data quality for regulatory submissions