FDA LDT Rule Raises Question of Whether FDA Should Regulate Diagnostic Testing

Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in the Bloomberg Law article, “FDA Lab Test Authority Set for Compliance Hurdles, Legal Fights.” The article discusses the U.S. Food and Drug Administration’s (FDA) final rule that would strengthen the administration’s oversight over laboratory developed tests (LDTs). The rule explicitly states that in vitro diagnostics (IVDs) include tests "manufactured" by a laboratory under the Federal Food, Drug, and Cosmetic Act, and the preamble discussion outlines a five-stage enforcement discretion phaseout plan. The FDA's phaseout plan covers most LDTs and takes place over a four-year period.

Regarding the question of whether the FDA possesses the legal authority to regulate LDTs, Davar told Bloomberg Law that “there’s going to continue to be this open question from various stakeholders of should this rule be the way FDA gets its authority to regulate diagnostic testing.”

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