DeGette, Bucshon Reintroduce VALID, Without Academic Center Carveout

Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) on Wednesday (March 29) revived a key bill that would overhaul how FDA regulates diagnostic tests, but the legislation excludes some carveouts for academic medical centers that were included in a previous discussion draft of the bill. The bill, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would establish a risk-based regulatory framework for laboratory-developed tests and create a user fee program for in-vitro clinical tests. The bill aims to remedy issues...