On September 30, 2014, the U.S. Food and Drug Administration's (FDA or Agency) Center for Devices and Radiological Health (CDRH) formally released the two draft guidance documents which detail how the Agency plans to regulate the laboratory developed tests (LDT) industry.

  • Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests1
  • Draft Guidance: Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests2

The draft framework guidance is nearly identical to the proposal FDA released on July 31, 2014, as part of its notification to Congress of its intent to actively regulate the LDTs. A full analysis of FDA's proposal is available in our August 2014 Advisory, "FDA's Risk-Based Laboratory Developed Tests Proposal Would Transform the Regulation of Diagnostic Testing in the U.S."3

While the release of the two draft documents represents the next formal step in the Agency's proposal to regulate LDTs since the July notification to Congress, many affected parties have been actively discussing and debating the issue. At a September 9, 2014, hearing of the House Energy and Commerce Health Subcommittee, FDA and representatives of both the clinical laboratory industry and the traditional diagnostic kit manufacturers offered testimony and opinions on the impact and legality of FDA's proposal.

On behalf of the clinical laboratory industry, American Clinical Laboratory Association President Alan Mertz summed up the LDT industry's major concerns with and opposition to the policy.  Mr. Mertz clarified his organization's fundamental disagreement with the policy and its belief that FDA lacks the statutory authority to regulate LDTs.  On the other side of the issue, Andrew Fish, Executive Director of AdvaMedDx, a trade association representing manufacturers of traditionally FDA regulated medical diagnostic tests testified to his groups' general support for the Agency's efforts to actively regulate LDTs and highlighted the current dichotomy between regulatory oversight of LDTs and diagnostic test kits.