Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)

In a surprising reversal of policy that had already been reversed in recent months, the US Department of Health and Human Services (HHS) announced that the US Food and Drug Administration (FDA) will once more enforce premarket review requirements for Laboratory Developed Tests (LDTs). The Nov. 15 announcement comes just over a year after HHS removed FDA authority over LDTs in response to the COVID-19 public health emergency.

FDA LDTs Regulation during the COVID-19 Crisis

The COVID-19 public health emergency exposed the weaknesses in the FDA’s makeshift system of regulating LDTs via its legislative authority over new medical devices. The agency’s attempts to assert 510(k) premarket control over LDTs in the first days of the crisis at a time when innovative COVID-19 tests were in desperate need drew widespread criticism. FDA red tape was seen as hampering the effectiveness of pandemic response.

FDA responded in March 2020 by unveiling a new policy empowering laboratories to develop and utilize their own tests, provided that they notify the agency that they were shipping products. In May, when it had become clear that the new policy had gone too far in the other direction by allowing for junk tests to reach the market, the FDA changed course by requiring Emergency Use Authorization (EUA) for diagnostic tests.

The next twist came in August 2020 when HHS took matters into its own hand by ordering FDA not to require premarket review for LDTs. The move, which was part of the Trump administration’s broader efforts to cut red tape impeding business, caught the laboratory industry by surprise and drew widespread criticism, including from influential former FDA Commissioner Scott Gottlieb, who warned of the new policy’s potential to undermine the agency’s ability to provide critical advice to test developers and crack down on bad tests.

New HHS Policy Restores Premarket Review of LDTs

Now, the pendulum has swung back again. Supplies of COVID-19 tests have stabilized. And the agency has had to recall a number of new tests amid concerns about their accuracy. On Nov. 15, HHS announced that the previous policy of allowing makers of LDTs to bypass the 510(k) premarket review clearance and EUA processes has impaired FDA’s ability to address problematic COVID-19 tests. From now on, according to HHS secretary Xavier Becerra, the historical review rules will apply and LDTs will not receive separate treatment.

As a result of the new/old policy, makers currently offering tests launched without submission of an EUA request will have to submit an EUA request. In addition, the agency will review pending EUA request submissions for LDTs. If the agency does not subsequently approve the EUA request, it will notify the test maker who will then have to stop marketing the product within 15 calendar days.

The new HHS policy also establishes new limits on which COVID-19 LDTs tests can have access to the EUA pathway to market.