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HHS Says FDA Can't Regulate Lab-Developed Tests Without Notice, Comment Rulemaking

NEW YORK – The US Department of Health and Human Services said on Wednesday that it has determined that the US Food and Drug Administration will not require premarket review of laboratory-developed tests without notice and comment rulemaking.

The HHS action, which the agency said is consistent with two executive orders on reducing regulations and associated costs issued by the President, recapitulates a claim made for years by many in the laboratory industry that the FDA cannot expand its authority over LDTs through guidances, but must do so through notice-and-comment rulemaking, a much more involved process. Guidances, historically, have been the FDA's preferred method of articulating its regulatory requirements over segments of the lab industry.

Among the more immediate impacts of the HHS decision will be to allow laboratories to offer LDTs for SARS-CoV-2 without first taking them through FDA's Emergency Use Authorization process, though HHS noted, "Those with an active EUA to use an LDT to detect the virus causing COVID-19 or its antibodies are unaffected by this announcement."

The question of FDA's authority to regulate LDTs has been an issue within the lab industry for years but has more recently drawn significant attention from Congress, where legislators have recently introduced bills that would codify the agency's role in regulating LDTs.

In March, a bipartisan-backed bill called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was introduced in the Senate and House of Representatives. The VALID Act would create a new risk-based oversight framework for so-called in vitro clinical tests, a category comprising lab-developed tests and test kits, and bring them all under FDA's aegis.

That was followed by a bill introduced later in the month by US Sen. Rand Paul (R-Kentucky) called the Verified Innovative Testing in American Laboratories (VITAL) Act, which would take regulation of LDTs out of FDA's hands.

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