Lawmakers are circulating draft legislation that would create a new regulatory category, distinct from medical devices, combining in vitro diagnostics and laboratory-developed tests. The representatives say they don't have specific timing in mind for moving the bill forward. But it is being circulated just as the FDA user-fee reauthorization process is getting off the ground, presenting a possible legislative vehicle.
Two lawmakers in the US House, one Republican and one Democrat, are circulating draft legislation to remake oversight of lab diagnostic assays.
The lawmakers say the timing for moving the legislation forward has yet to be considered while they collect stakeholder feed bill. But the draft bill happened to be put out...