6 Things Labs Need to Be Aware of in 2023
Clinical laboratories and healthcare providers as a whole received a number of welcome reprieves from potential payment cuts and burdensome regulation as 2022 drew to a close. But that doesn’t mean many of these issues couldn’t be resurrected in a different form in...
VALID Act Excluded from Omnibus Package, Payment Cuts Delayed
In a win for laboratory innovation, the VALID Act, which would have created a new risk-based framework for regulating lab developed tests (LDTs), was excluded from the year-end omnibus spending package recently finalized by Congress, meaning the legislation...
Paths to Consider When Commercializing Your LDT
UPDATE: On May 6, 2024, FDA issued a new rule amending the regulatory definition of in vitro diagnostic (IVD) device to include laboratory-developed tests (LDTs) and ending the agency’s longstanding policy of generalized enforcement discretion. Learn more about these...