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# Congress Should Ensure FDA Test Review Authority: Pew
- URL: https://www.fdaweb.com/congress-should-ensure-fda-test-review-authority-pew/
- Published: 2021-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:59:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149361

The Pew Trusts says the Covid-19 pandemic has demonstrated the value in FDA reviewing laboratory-developed tests (LDTs) and says Congress should adopt reform legislation that would maintain the agency’s central role in overseeing diagnostic tests. An online [paper](https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/05/covid-19-tests-highlight-need-for-strengthened-fda-oversight-and-diagnostics-legislation?ref=fdaweb.com) says the agency’s regulatory authority over tests remains unclear, especially in light of an HHS 2020 decision to limit FDA’s oversight over LDTs.

“Congress should pass reforms, such as those proposed by the VALID Act (Verifying Accurate Leading-Edge IVCT Development Act) that would improve regulation of all *in vitro* clinical tests,” Pew says. The group says reforms would create a unified and risk-based oversight system while also protecting the emergency use authorization powers FDA used to increase Covid-19 testing capacity.

“Any legislative solution … should maintain FDA’s central role in overseeing diagnostic tests, and should ensure that they are held to the appropriate risk-based standards for quality, accuracy, and reliability, regardless of where they are developed and used,” Pew says.