FDA resumes enforcement relating to laboratory developed tests

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in one of the first FDA enforcement actions against a clinical laboratory for services offered as laboratory developed tests (LDTs) in more than five years, and certainly the first such action of which we are aware since FDA announced in late 2016 that it would not finalize the proposed framework and guidance documents for the regulation of LDTs.

At that time, FDA elected to revert to the enforcement discretion approach the agency had employed for LDTs between 1998 and 2014 where FDA refrained from enforcing its requirements for assays that were developed, validated, and performed in a single CLIA laboratory with a physician order. While FDA and stakeholders have proposed legislation (e.g., The Diagnostic Accuracy and Innovation Act) to provide FDA greater explicit authority over LDTs, FDA has long held that the agency already has authority to regulate these services.

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