Letter to the Office of Management and Budget regarding FDA's final rule on laboratory-developed tests
The undersigned organizations support the regulation of laboratory-developed tests (LDTs) by the Food and Drug Administration (FDA) in order to ensure that patients and doctors are getting results that are clinically meaningful and accurate. LDTs are diagnostic tests that are developed and used in a single laboratory. They have become increasingly important in clinical practice but have evaded regulation by FDA for decades. LDTs that are inaccurate or not supported by scientific evidence put patients at risk for adverse health outcomes and increase healthcare costs.
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FDA proposed rule Medical Devices: Laboratory Developed Tests regulate LDTs as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) / Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments / Regulatory Impact Analysis (RIA) / House Energy and Commerce Subcommittee on Health / VALID Act / Verifying Accurate Leading-edge IVCT Development Act / Richard Revesz / Office of Information and Regulatory Affairs / Center for Science in the Public Interest CURED Nfp (Campaign Urging Research for Eosinophilic Diseases) Doctors for America Elijah-Alavi Foundation FARE (Food Allergy Research and Education) International Center for Technology Assessment International FPIES Association (IFPIES) Medical Device Problems MRSA Survivors Network National Center for Health Research Our Bodies Ourselves Patient Safety Action Network Stupid Cancer, Inc. USA Patient Network U.S. PIRG Washington Advocates for Patient Safety Woodymatters