On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations for LDTs during the COVID-19 pandemic. In withdrawing this policy, HHS said that it “no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.”
Morrison & Foerster's FDA Regulatory and Compliance team has closely followed developments related to LDTs and Emergency Use Authorizations during the pandemic. To help developers and industry understand the implications of this policy change, Brigid Bondoc, Of Counsel in Washington, D.C. moderated a discussion featuring our FDA Regulatory and Compliance co-chairs Stacy Cline Amin, former FDA Chief Counsel and Partner in Washington, D.C., and Bethany Hills, Partner in New York. Both Stacy and Bethany provided their unique insight and perspective that can be viewed below.
What did HHS announce this week?
HHS reversed a policy issued in August 2020 prohibiting FDA from requiring premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations for LDTs during the COVID-19 pandemic. On November 15, 2021, HHS withdrew this policy and said that it “no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.”
The longstanding approach references FDA’s longstanding view that LDTs are subject to FDA’s jurisdiction as medical devices, like any other in vitro diagnostic test, though FDA has a long history of mostly exercising enforcement discretion with respect to the premarket review requirements for LDTs.
FDA followed up on the HHS announcement with a new guidance on COVID-19 testing. What are the key points of the new policy?
FDA withdrew the “notification” and other policies issued in the early days of the pandemic that provided flexibility for certain LDTs and serology tests to market tests without an EUA. FDA will now require an EUA to market these tests, and if an EUA request has not already been submitted, developers have 60 days from the date of the guidance to submit an EUA request.
How will FDA prioritize those tests?
FDA has articulated clear and specific priorities for tests that it will review:
- Diagnostic tests (molecular and antigen) that can be used at the POC or completely at home and able to be used on symptomatic and nonsymptomatic;
- Laboratory-based molecular diagnostic tests that are highly sensitive, high throughput, intended for pooling, home specimen collection, screening, or detection of multiple analytes, and from experienced developers (i.e. developers who have already received an EUA);
- Home specimen collection kits intended for use with laboratory-based molecular diagnostic tests; and
- Serology tests intended for quantitative measurement of antibody titers or qualitative detection of neutralizing antibodies.
For all of these categories of tests, FDA only intends to review tests from developers who have indicated the ability to scale up manufacturing capacity of ≥500,000 tests per week within 3 months of authorization.
What does this mean for tests that do not have the capacity for over 500,000 tests per week or otherwise do not fall into a prioritized category?
FDA has indicated in the guidance that developers can make an argument to FDA as to why their test should be reviewed and authorized even though it does not meet the conditions for prioritization, or they can seek premarket review through the 510K or de novo pathways.
However, if FDA notifies a developer that it declines to issue an EUA, the developer has 15 calendar days from the date of notification to stop marketing the test or risk enforcement action from FDA. It is not clear at this point in time how many tests will need to withdraw from the market, but we expect that many tests will be affected.
What does this mean for non-COVID-19 LDTs?
FDA’s more recent history with LDTs over the last 10 years indicates a concern about the safety and efficacy of the growing market, and a willingness to take compliance action and potentially even enforcement action against LDTs that it believes pose a public health risk. Moreover, its experience regulating COVID-19 tests may indicate the agency will increase its oversight of LDTs.
The state of uncertainty over the last decade has led many to support a legislative solution that would provide a risk-based framework for the regulation of LDTs that would ensure safety and efficacy of diagnostic testing while continuing to promote innovation. In particular, many are closely watching the VALID Act.
The Medical Device User Fee Amendments provide a must-pass legislative vehicle that may provide the perfect timing for diagnostics reform in 2022.