The Professional Relations Committee formed a Task Force to develop a proposal that modernizes the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and maintains oversight of Laboratory Developed Testing Procedures (LDPs) under existing regulations. AMP released the proposal on November 9, 2023, which serves as an alternative legislative pathway that will expand CLIA to ensure high quality testing is maintained, The proposal clarifies analytical and clinical validity and provides additional assurances that standards are being met. Additionally, the proposal requires LDP information is easily accessible by ordering physicians and the public, without elements that would curtail the ability of medical professionals to offer vital clinical services. The proposal consists of a tiered, risk-based structure that avoids duplication of activities within and between federal agencies.
Proposal Available Here: CLIA Modernization Proposal
Over three decades old, the CLIA regulations need to be modernized to better reflect advancements in molecular testing. This effort would also lead to a flexible system of oversight that fosters innovation and ensures patients have continued access to precise, accurate, and the most up-to-date tests. Over 50 stakeholders have urged Congress to modernize CLIA and AMP has supported this cause with our 2023 CLIA Modernization Proposal. You can read more about how AMP's proposed legislation and endorse it here:
Inside Health Policy - More Groups Back AMP's LDT Plan as Senate Staffers Urge Stakeholders to Press for Action
Genetic Engineering & Biotechnology News - Drawing Battle Lines over Lab Tests
Clinical Lab Products Magazine - Procedures, Not Tests
Diagnostic World News - Association for Molecular Pathology Puts Forth New Plan to Regulate Laboratory Developed Tests
Inside Health Policy - Molecular Pathology Association Floats Risk-Based CLIA Modernization Plan
Laboratory Testing and Patient Care - View Video
Signs from the 2014 Annual Meeting: Are you ready to be a "manufacturer"?
AMP Position Statement: Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests
FDA's website devoted to all information relevant to the draft framework: www.FDA.gov/LDTs
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