CLIA Modernization of LDPs

Enhances Transparency • Ensures Quality • Preserves Innovation

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

Tell Congress It's Time to Modernize CLIA

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:

Legislative Proposal
to Modernize CLIA

Frequently Asked Questions
on Legislative Proposal

Section by Section Summary
of Legislative Proposal

Endorse CLIA
Legislative Proposal