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Sparking Discussion and Adding Fuel to the Fire: FDA Discussion Paper On Laboratory Developed Tests (LDTs) 

by James C. Shehan, Esq., Alan Wovsaniker, Esq., and Donna Hanrahan, Esq.

Published: February, 2017

Submission: February, 2017


On January 13, 2017, the U.S. Food and Drug Administration (FDA) released a discussion paper on laboratory developed tests (LDTs)1 that outlines a substantial lessening of the level of regulation proposed in a pair of 2014 draft guidances2 that, in late November, FDA announced it would not be finalizing. While in no way a formal agency position or proposal, the discussion paper is intended by FDA to memorialize its work on the topic to date and to spark public dialogue “on future LDT oversight.” The agency also portrays the discussion paper as an attempt to synthesize a broad range of stakeholder feedback and to balance patient protection with continued access and innovation.

Although lauded by some in the laboratory business, the discussion paper has raised concern among patients, scientists, advocates, caregivers, health care professionals, and other stakeholders who have argued for strengthened FDA oversight in light of the increasing complexity of molecular tests. On January 24, 2017, less than two weeks after the publication of the discussion paper, over 30 disease advocacy groups, including the American Cancer Society and the American Heart Association, wrote a letter urging Congress to work with FDA to craft a regulatory framework for LDTs as a priority early in the 115th Congress.3 Among other things, the letter calls for premarket review, emphasizing that FDA’s lack of oversight has become outdated as the complexity of LDTs has grown.

Focused Oversight: Premarket Review

Under FDA’s proposed framework, most LDTs that are already on the market would be “grandfathered” and need not comply with most or all FDA regulatory requirements, including premarket review, quality systems, and registration and listing. In addition, six categories of new and significantly modified LDTs could take advantage of the same loose regulatory scheme, including LDTs for rare diseases; certain LDTs for allele typing, antibody screening, and organ and tissue cross-matching; and LDTs whose output is the result of manual interpretation by a qualified professional.FDA would reserve its right to enforce premarket review, quality systems, and other applicable requirements for any LDT, including the above categories, if the agency determines that: (1) the LDT is not, or lacks data to show that it is, analytically and clinically valid; (2) the LDT manufacturer has engaged in deceptive promotion; or (3) there is a reasonable probability that the LDT will cause death or serious adverse health consequences.








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