Senate Seeks to Reform Diagnostic Oversight via User-Fee Bill, Sparking Mixed Response

U.S. lawmakers again are trying to pass legislation to create a new regulatory framework for in vitro and laboratory-developed tests, this time by modifying the FDA user-fee bill that is now working its way through Congress.

The revised bill from the Senate Committee on Health, Education, Labor and Pensions (HELP) features a modified version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act. The act split the diagnostic industry when lawmakers previously tried to pass it in 2020.

The VALID Act remains an attempt to create a tiered regulatory system for in vitro clinical tests. Lawmakers want to assign all tests, regardless of whether they are developed by a laboratory or commercial entity, to one of three risk categories. 

Tests that likely would cause negative outcomes — such as serious or irreversible harm or death — if they give an undetected inaccurate result, will go in the high-risk category and be subject to premarket review. The proposal exempts low-risk tests from premarket review and proposes a middle ground for all other tests by creating a voluntary “technology certification” program that allows companies to bring products to market by showing they have suitable internal processes for validation. Once on the market, companies can tweak their moderate-risk tests without undergoing FDA review.

Source: https://www.medtechdive.com/news/senate-reform-diagnostic-oversight-user-fee-bill/624169/