Mitchell Parrish, JD, RAC, CIP, VP of Legal and Regulatory Affairs
IVDs are incredibly important. In some estimates, IVDs influence around 70% of medical decisions while only accounting for about 2% of healthcare expenditure in the U.S. In other words, IVDs provide bang for the buck. This is also true in clinical investigations, where IVDs have enabled significant advances. The FDA did not randomly issue its draft guidance on IVDs. The use of IVDs is widespread and the FDA is hoping for clearer application of those regulations intended to offer some protection to participants in clinical trials utilizing IVDs.