Needs and Opportunities (Problem/Challenge):  To accelerate innovation for in vitro diagnostics (IVDs) and to enable patients and health care professionals to have access to safe and effective IVD technologies, we must explore barriers, innovative methodologies, and approaches in clinical evidence generation and utilization in addition to traditional clinical studies/trials.

Vision (Solutions):
To build a framework for utilizing RWD as a source of evidence that can be used to support regulatory and reimbursement decision-making for in vitro diagnostics.

Value to Stakeholders:

  • Patients:
    • Expedited access to medical device technologies
    • Reduce number of patients exposed to risks from clinical trial participation
  • Industry:
    • Decreased time when developing clinical evidence
    • Lower costs for clinical evidence generation
    • Support CDRH’s mission to maintain US leadership in medical device innovation and expedited patient access to new technologies
    • Support CDRH’s goal of increasing the use of real-world evidence to support regulatory decision making