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Members of Congress Re-Introduce Bill to Reform Laboratory Developed Test Oversight

June 25, 2021

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Christa Wagner, Manager, Government Relations

Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) and Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) reintroduced legislation to reform the federal government’s oversight of laboratory developed tests (LDTs) on June 24 through the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.

Currently, the Centers for Medicare & Medicaid Services regulates laboratories performing LDTs, including many in academic medical centers, through the Clinical Laboratory Improvement Amendments (CLIA), with state laboratory certification programs and professional accrediting bodies providing additional regulation. The VALID Act would create a new framework for the U.S. Food and Drug Administration (FDA) to regulate LDTs as a new category of in vitro diagnostic called in vitro clinical tests (IVCTs).

Additionally, the bill would:

  • Create a new product category for diagnostic and lab tests, putting their review and approval under the authority of the FDA beginning four years after passage of the bill.
  • Grandfather in any current diagnostic test already being used by health care professionals.
  • Create a new system for hospitals and labs to use to submit their tests electronically to the FDA for approval.
  • Allow for the lawful marketing of certain IVCTs without prior FDA approval in the case of a public health emergency.

Regarding the provision for public health emergency exemptions, DeGette noted in a press statement that the VALID Act “will ensure that our hospitals and laboratories have the ability to respond quickly, accurately and efficiently to help us detect and stop the spread of these diseases before it’s too late.”

Burr added, “The coronavirus pandemic demonstrated the importance of diagnostic testing, particularly in the nation’s ability to respond quickly and effectively. Our testing framework must keep pace with today’s medical advancements to better prepare us for the next generation of products to detect diseases and help Americans engage in their health care choices.”

The members first introduced the VALID Act in the 116th Congress. No additional timeline has been provided for consideration of the bill by the committees of jurisdiction.

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