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CLIA Modernization of LDPs


Enhances Transparency • Ensures Quality • Preserves Innovation

 

A working group of the Professional Relations Committee developed a proposal to modernize the CLIA regulations and maintain oversight of Laboratory Developed Testing Procedures (LDPs) under those regulations. AMP released the proposal on August 4, 2015. The working group is to be commended for wrestling with the issues and drafting a viable proposal that will provide reassurance that clinical validity is being assessed and information about LDPs is easily accessed 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

 

View Proposal Presentation Slides: Proposal Presentation

 

Press on AMP's Proposal

 

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

 

Mendelspod - Still Unhappy with FDA's Plan to Regulate LDTs, Professional Lab Groups Go Direct to the Senate

 

GenomeWeb - Pathologists Take Alternative Lab Test Regulation Proposal to Senate

 

Inside Health Policy - Molecular Pathology Association Floats Risk-Based CLIA Modernization Plan

 

Oversight of LDPs Position Statments, Comments, and Reference Materials

 

AMP's Analysis of FDA's Report Titled "The Public Health Evidence for FDA Oversight of LDTs: 20 Case Studies"

 

AMP's Written Testimony to Hearing on "Examining the Regulation of Diagnostic Tests and Laboratory Operations"

 

Laboratory Testing and Patient Care - View Video

 

AMP's Principles for Oversight of LDPs

 

AMPs Comments to House E&C Committee on Regulation of In Vitro Clinical Tests Draft Legislation

 

AMP's written comments to FDA on LDPs

 

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

 

View all AMP Position Statements and Letters

 

For more information, please contact policy@amp.org.