HHS said on Wednesday it has determined that notice and comment rulemaking is required before the U.S. Food and Drug Administration can require premarket review of laboratory-developed tests.
The HHS action, which the agency said is consistent with two executive orders on reducing regulations and associated costs issued by the president, establishes a claim made for years by much of the laboratory industry that the FDA does not have the authority to regulate laboratory-developed tests. The FDA, on the other hand, has maintained that it does have this authority, though it has not traditionally used it.
Among the more immediate impacts of the HHS decision will be to allow laboratories to offer laboratory-developed tests for SARS-CoV-2 without first taking them through the 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 the FDA's authority to regulate laboratory-developed tests has been an issue in 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 such tests.
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 the FDA's aegis.
That was followed by a bill introduced later in the month by US Sen. Rand Paul (R-Ky.) called the Verified Innovative Testing in American Laboratories (VITAL) Act, which would take regulation of laboratory-developed tests out of the FDA's hands.
This story first appeared in our sister publication, Genomeweb.