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.

MDIC’s IVD RWE project aims to build a framework for utilizing Real-World Data (RWD) as a source of evidence that can be used to support regulatory and reimbursement decision-making for in vitro diagnostics. Patients can benefit from this project by gaining expedited access to medical device technologies. In addition, with this project, there should be a reduced number of patients exposed to risks from clinical trial participation. Industry stakeholders should experience decreased time when developing clinical evidence and lower costs for clinical evidence generation. This project supports CDRH’s mission to maintain US leadership in medical device innovation and expedited patient access to new technologies. It also supports CDRH’s goal of increasing the use of real-world evidence to support regulatory decision making.