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AdvaMedDx VALID Act Resources
AdvaMedDx supports the establishment, through legislation, of a modernized and predictable, risk-based diagnostics regulatory framework under the Food and Drug Administration (FDA) to which all developers of in vitro clinical tests (IVCTs) would be subject. Under a modernized new framework, Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) would be known collectively as IVCTs. The introduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) in the Senate, and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) in the House, is a major milestone toward modernizing IVCT oversight, making diagnostics regulatory reform a reality. The VALID Act would aim to establish a single, diagnostics-specific, risk-based regulatory framework under the FDA for all IVCTs.
- Resources and Background Materials on The VALID Act (introduced 3.5.20)
- Resources and Background Materials on The VALID Act Discussion Draft
(generated prior to bill introduction)