VALID Act of 2025
Key claim: The VALID Act of 2025 (HR3694) was introduced in the 119th Congress and referred to the House Committee on Financial Services.
Abstract
(HR3694 · 119th Congress) Latest action (2025-06-03): Referred to the House Committee on Financial Services.
Why this matters
The VALID Act would reshape how FDA regulates diagnostic tests, particularly laboratory-developed tests that currently sit in an enforcement-discretion gray area outside the medical device framework. If enacted, it would affect what tests clinical labs can offer, how quickly new diagnostics reach patients, and what safety and validity assurances providers and insurers can rely on. As an introduced bill referred to committee, it faces a long path before any change in coverage or practice.