by Claire Carbary

FDA Intended Draft Guidance and Enforcement of Laboratory Developed Tests

On July 31, 2014 the FDA sent a document outlining the details of planned draft guidance on laboratory developed tests (LDTs) to Congress. The guidance outlines a risk-based framework that will be applied to address the regulatory oversight of a subset of in vitro diagnostic devices (IVDs). An overview of the document and FDA’s plans for regulating these devices is provided below.

FDA defines LDT as an “IVD that is intended for clinical use and designed, manufactured and used within a single laboratory.” Although these devices are, by definition, subject to regulation by the FDA, the agency has historically exercised enforcement discretion and has not enforced provisions under the FD&C Act and FDA regulations with respect to LDTs.

FDA LogoThis draft guidance signals the FDA’s plans to step-up enforcement efforts as many laboratories are offering devices as LDTs even though they do not meet FDA’s definition of an LDT. The details document indicates that the failure to follow FDA requirements results in a lack of controls to ensure appropriate design, manufacture, and safety and effectiveness of these tests. The FDA indicates that this creates potential increased risk for patients and that they have “serious concerns regarding the lack of independent review of the evidence of clinical validity of LDTs.” Furthermore, patients and even treating physicians often have no knowledge that the device being used is not FDA cleared or approved.

Due to these concerns the FDA has outlined a framework for oversight using the existing risk-based classification (Classes I-III) for medical devices. The details document describes FDA’s plan for enforcement depending on the type of LDT, which is summarized in the table below:


Original table available at:

The FDA notes that it intends to focus attention first on devices that pose a higher risk to patients, including:

  • those that act like companion diagnostics,
  • screening devices for serious diseases and/or conditions intended for use in asymptomatic patients with no other available confirmatory diagnostic product or procedures, such as screening for malignant cancers, and
  • Diagnostic devices for certain infectious diseases with high-risk intended uses

While the draft of the guidance is yet to be released, it is clear the implications of these requirements extend beyond the laboratories developing and administering these tests to the patients and doctors that utilize them. A number of groups and organizations have expressed concerns about the FDAs plans to regulate this area, and we expect to see much more discussion about this in the coming year.

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