Snapshot: LDT Labs Prepare for the Eventuality of FDA Oversight

May 1, 2015
Snapshot: LDT Labs Prepare for the Eventuality of FDA Oversight
Advocacy groups have alleged that the FDA lacks statutory authority to regulate LDTs, that the agency would not be able to bear the burden, and that the use of a guidance document circumvents requirements of rulemaking. [iStock/shock]

Nina Peled, Ph.D.

Plamena Entcheva-Dimitrov, Ph.D.

The FDA defines a laboratory developed test (LDT) as a type of in vitro diagnostic device (IVD) intended for clinical use that is designed, manufactured, and used within a single laboratory. According to the FDA, enforcement discretion with respect to LDTs had been exercised because they were traditionally simple, small-scale testing laboratories, serving a limited local population and were typically used and interpreted directly by physicians working within a single institution.

As technology has advanced, LDT labs have been able not only to further the uniqueness, sophistication, and complexity of their tests, but also to offer them across state boundaries. While such advances strive to improve health outcomes, the FDA feels that they no longer fit the above narrow definition of a “Traditional LDT.” From a perspective of risk to public health, the distinction between a test manufactured in a lab and one produced by a conventional IVD manufacturer has become blurred, yet only the latter is subject to the FDA’s scrutiny and oversight.  

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