Pew Proposes Improvements to VALID Act’s Reforms of Diagnostic Test Oversight

COVID-19 and responses from federal health leaders reinforce need for congressional action

The Pew Charitable Trusts wrote to the U.S. House and Senate sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act on Sept. 28, recommending bill changes to ensure that federal oversight of diagnostic tests adequately protects Americans from risks posed by these important medical tools. The legislation, introduced in March 2020, seeks to bring all diagnostics under one risk-based regulatory system, and Pew’s comments identify ways to strengthen the bill so that patients and their health care providers can benefit from innovative tests and trust the accuracy of the results.

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Safeguards Are Needed to Curb Unreliable COVID-19 Tests

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A decision announced Aug. 19 by the federal Department of Health and Human Services (HHS) complicates the already fragmented regulatory system for diagnostics and could let inaccurate COVID-19 tests on the market, potentially undermining efforts to control the disease’s spread.