diagnostic

Congress Introduces New Legislation for Diagnostics Regulation

March 06, 2020

McDermott+Consulting

On March 5, 2020, Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., introduced the Verifying Accurate Leading-edge IVCT Development Act of 2020 (VALID). The bill would create a new test product category, in vitro clinical tests (IVCTs), which comprise test kits and laboratory-developed tests, and gives FDA authority to review and approve these IVCTs.

An identical version of this bill – sponsored by Sens. Michael Bennett, D-Colo., and Richard Burr, R-N.C., – was introduced in the Senate.

116th Congress 2D Session

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