Reintroduced "VALID Act" Would Give FDA Explicit Authority to Regulate LDT's
On June 24, 2021, Senator Richard Burr (R-NC), Senator Michael Bennet (D-CO), Congresswoman Diana DeGette (D-CO), and Congressman Larry Bucshon (R-IN) introduced the Verifying Accurate Leading-Edge IVCT Development Act (VALID) Act of 2021, a modified version of the same bill introduced in 2020. The VALID Act of 2021 would give the Food and Drug Administration explicit authority to regulate laboratory developed tests.
NILA is analyzing the newly introduced VALID Act of 2021 and will provide NILA members with an analysis of how the VALID Act of 2021 differs from the bill introduced in 2020 and what the VALID Act of 2021 would mean for laboratories if enacted.
A statement from NILA on the introduction of the VALID Act of 2021 is available here (PDF ).