Is the FDA About to Regulate Lab-Developed Tests?

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently released a joint statement suggesting that the FDA is about to end its decades-long policy of declining to regulate lab-developed tests (LDTs). The statement casts the policy as outdated and suggests that the FDA is about to impose regulation to treat LDTs with the same approach as all other laboratory tests.

Testing by clinical laboratories is regulated by both the FDA and by the Clinical Laboratory Improvement Amendments (CLIA), as administered by CMS. The FDA regulates medical devices, including in vitro diagnostic products (“IVDs”). The FDA considers LDTs to be IVDs that are intended for clinical use and are designed, manufactured, and used within a single laboratory. CLIA, on the other hand, regulates the laboratory itself and classifies LDTs as “high complexity tests,” with corresponding standards imposed on the laboratory. Importantly, regarding the LDT itself, CLIA generally requires only analytical validation, which can occur after testing has already begun. LDTs may also be subject to more stringent state and private sector oversight.

Historically, the FDA had exercised enforcement discretion and not regulated LTDs, but this began to change in recent decades and accelerated during the COVID-19 pandemic. The pandemic caused an explosion in the need for quick, accurate, and cost-effective means to detect the virus that causes COVID-19. Many clinical labs responded by developing LDTs to detect COVID-19. As LDTs, labs were quickly able to innovate and begin bringing tests for COVID-19 to market. FDA responded by muddying the waters and adding regulatory burden. Initially, the Department of Health and Human Services (HHS), then under the Trump administration, released guidance that, during the public health emergency (PHE), LDTs for COVID-19 would not require pre-market approval. FDA then, in seeming contradiction of HHS, determined that the at-home collection kit of a COVID-19 LDT was distinct from the test itself and subject to FDA regulation. Later in the pandemic, HHS, now under the Biden administration, changed policy again and allowed the FDA to regulate all COVID-19 LDTs.

FDA now seems poised to expand its regulation of LDTs even further. In October 2023, the FDA issued a notice of proposed rulemaking to phase out the FDA’s current approach to LDTs. If finalized, LDTs would generally fall under the same enforcement approach as other tests. CMS has come out in support of the FDA’s proposal.

Clinical labs may seek to secure approval for their LDTs for other reasons, such as compliance with state law and payor policies, consumer reassurance, or other reasons. Labs that rely on the FDA’s enforcement discretion should be prepared for its eventual end, as well as increased scrutiny of small labs by regulatory agencies and insurance carriers.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in healthcare law and regulation. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.