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Medical Devices / Regulatory Affairs

Stakeholders Urge Congress to Update Clinical Laboratory Diagnostics Legislation

May 25, 2018
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Industry and other interest groups called on Congress to modernize legislation covering clinical laboratory diagnostics to bring it into the 21st Century.

A May 9 letter sent to Sen. Lamar Alexander (R-Tenn.), Sen. Patty Murray (D-Wash.), Rep. Greg Walden (R-Ore.) and Rep. Frank Pallone (D-N.J.) urges them to move quickly on comprehensive legislative reform to ensure patients have access to innovative and high quality clinical laboratory diagnostics.

Signed by organizations representing patient advocates, providers, laboratories and diagnostics manufacturers, the letter says there is an urgent need to reform regulations covering laboratory developed tests (LDTs) and in vitro diagnostics (IVDs). Currently, the FDA regulates IVDs but does not actively regulate LDTs.

“FDA Commissioner Scott Gottlieb has made repeated public comments that comprehensive legislative reform of clinical laboratory diagnostics is timely and appropriate,” the letter says.

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