Description
The scope of the FDA’s authority over laboratory-developed tests (LDT) has long been a source of controversy. Now, makers of LDT will have to adjust to the brand-new final rule affirming LDT are in vitro diagnostic products that will be regulated by the FDA as medical devices. This ruling will likely trigger an avalanche of litigation from various stakeholders, as the FDA also intends to phase out the enforcement discretion it has historically applied to most LDT.
In this webinar attendees will gain a clear understanding of the immediate impact of the new LDT final rule, the many changes that will accompany it, and its long-range implications for the industry.