This May, the FDA-issued final rule on laboratory developed tests (LDTs) sent shockwaves through the industry. If your lab uses LDTs, your teams may be responsible for unprecedented new documentation, compliance systems, and reporting to the FDA.
The FDA set a four-year timetable to implement the new requirements. To help your lab prioritize its compliance strategy, we created the checklist as a means to determine where your lab stands in relation to the FDA’s final rule.