VALID Act of 2025 (HR3694)
Current understanding
The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2025 (HR3694) would establish a risk-based FDA framework for in vitro clinical tests (IVCTs), including laboratory-developed tests (LDTs), creating a regulatory pathway distinct from the current medical device classification system. Introduced in the 119th Congress and referred to the House Committee on Financial Services, the bill continues prior VALID Act efforts from earlier Congresses. Status: introduced.