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# VALID Act Reintroduced
- URL: https://www.fdaweb.com/valid-act-reintroduced/
- Published: 2023-03-30T12:00:00.000Z
- Updated: 2026-09-14T18:22:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154099

Reps. **Larry Buschon** (R-IN) and **Diana DeGette** (D-CO) have reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, that they say would create a new framework to verify the accuracy of various medical tests that doctors and patients rely on to make important health decisions. In a [statement](https://degette.house.gov/media-center/press-releases/lawmakers-move-reform-diagnostic-testing-us?ref=fdaweb.com) (contains a link to the bill text) the two say the bill would modernize the review process for diagnostic testing, clarify the regulatory authority between FDA and the Centers for Medicare and Medicaid Services, and limit duplication between the two agencies by ensuring uniform standards are in place that support innovation.

The statement says that FDA has for years urged Congress to enact legislation that will both solidify its authority to review such tests and, more importantly, provide the agency the framework and resources it needs to effectively do so. “The legislation introduced by Buschon and DeGette will achieve both those objectives,” it says.

The representatives say the bill would create:

- a new product category that differentiates diagnostic and lab tests from medical devices;
- a new system that allows hospitals and laboratories to submit their tests to FDA for review electronically, increasing the review process efficiency; and
- a new program to expedite the review of any diagnostic test that’s developed to address a current unmet need for patients, providing patients with access to breakthrough testing capabilities as soon as possible.

To ensure the legislation does not impede the ability of healthcare providers to continue treating patients while the reforms are being implemented, the statement says, the legislation has a provision to grandfather in any diagnostic test that is currently available to patients in the U.S.