Q&A: Unpacking The Latest VALID Act For Diagnostics

Medtech Insight interviewed Scott Danzis in a Q&A about the IVCT Development Act, which establishes a new regulatory category called “in vitro clinical tests,” to include current laboratory developed tests (LDT) services and in vitro diagnostics “IVD” in a single class that is distinct from other medical devices.

Scott says “If you’re on the IVD side, you’re used to FDA regulation; however, we would have a new risk framework, we would have a new set of standards and pathways if the bill is enacted.” “So there’s a lot in this bill – it’s 245 pages – and IVD manufacturers need to be engaged and understand what those approval pathways look like. And on the laboratory side, the same is true because this is going to be a new framework for laboratories, which currently are not subject to FDA review and approval of new tests. To have that new role for FDA would be a big deal,” he adds.

When asked if the FDA would have oversight over LDTs, Scott says, “The bill clearly gives FDA a role in the development of diagnostic tests, whether those tests are developed and commercialized as a kit – a traditional IVD – or developed and commercialized as a laboratory service. So yes, there’s no question that FDA would have a role under this statute.”