Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Draft Guidance Framework for Regulating Lab-Developed Tests

Laboratory developed tests (LDTs) are currently subject to comprehensive regulations under the Clinical Laboratory Improvement Amendments (CLIA). The Food and Drug Administration (FDA) announced that it intends to regulate LDTs as medical devices and outlined the structure of a regulatory framework that the agency intends to implement once a Guidance Document is finalized.

The FDA has worked with stakeholders for several years on the appropriate regulatory framework and the Coalition for 21st Century Medicine remains committed to that effort. However, critical questions still remain unanswered about how FDA’s proposed requirements can be implemented by laboratories. For example:

  • How will FDA labeling requirements apply in the absence of a distributed or tangible “box” on which to put a label, or a person or entity to “receive” the “box” or the “labeling”?
  • How will FDA define which activities performed in laboratories will constitute the FDA regulated laboratory test “device” (and therefore be deemed analogous to a test “kit” that is manufactured by a 3rd party then packaged in a box and distributed to a laboratory to perform), and which activities will be deemed the practice of laboratory medicine (which is outside FDA’s authority)?
  • How does FDA intend to apply its rules on test design and quality systems to laboratories, which also must comply with CLIA’s quality systems requirements on those same activities?
  • How will FDA manage conflicting regulatory requirements with respect to consultations with physicians about patient test results (CLIA requires disclosure of known information relevant to a patient as part of the practice of laboratory medicine whereas FDA “off-label” promotion rules may prohibit discussion of any information that FDA has not reviewed and approved)?

Additionally, the magnitude of the task that the agency is proposing to undertake in regulating LDTs as medical devices cannot be overstated. There are potentially thousands of CLIA labs that perform at least one high complexity test that FDA intends to review as a device. FDA will require substantial resources to establish and implement a new regulatory framework that recognizes the differences between LDTs and medical devices sold as kits.

The Coalition plans to submit public comments on the FDA’s proposed regulatory requirements to ensure patient access to new and innovative LDTs. The Coalition was formed in 2006 with the mission of working with the FDA to develop the appropriate regulatory pathway for advanced diagnostic tests that promote innovation and protect public health. We look forward to continuing our longstanding dialogue with FDA to achieve this goal.

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