The Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R.2369) was reintroduced in the House of Representatives on March 29 by Reps. Larry Bucshon, M.D. (R-IN), and Diana DeGette (D-CO).

If passed, this legislation would provide a regulatory framework to the U.S. Food and Drug Administration for in vitro clinical tests. The bill was referred to the House Energy and Commerce Committee and Ways and Means Committee to consider specific provisions in relation to the relevant subcommittees.

The FDA has long petitioned Congress to clarify the agency’s authority to regulate diagnostic testing and to provide a framework and resources to act on this authority. The VALID Act aims to provide the FDA with the authority necessary to oversee diagnostic testing and will create a system for hospitals and laboratories to submit tests to the FDA for electronic review to make the review process more efficient.

The VALID Act was previously introduced in the last legislative session as companion bills in the House and Senate (H.R.4128/S.2209), but the bills stalled in committee due to a lack of consensus among members.

The College of American Pathologists (CAP) announced the reintroduction of the VALID Act with little optimism that progress will be made for laboratory-developed test reform in the near term. CAP expects the FDA to initiate rule-making if Congress does not act during this legislative session.

We will provide updates on committee hearings and other legislative activities as they happen.