There has been speculation for over a year about how the Biden administration would handle the chronically vexing regulatory issues associated with lab-developed tests (LDTs). On November 15, 2021, we finally got our answer when the August 2020 policy enacted by the Trump administration was officially repealed. The Food and Drug Administration (FDA) has also released corresponding updates to several guidelines related to the test’s response to the ongoing public health emergency. Before summarizing all these extremely important developments, let’s give a brief history of what has happened to LDTs since the start of the pandemic.
As we’ve outlined in previous posts (see here and here), the FDA regulates the production of test kits by manufacturers of diagnostics under its medical device authorities, but in the past has exercised regulatory discretion to allow labs to use proprietary LDTs in accordance with rules established under the Clinical Laboratory Improvement Amendments (CLIA), administered and enforced by the Centers for Medicare and Medicaid Services (CMS). With the onset of the pandemic in early 2020, labs developing their own LDTs to provide COVID-19 testing and diagnosis were encouraged to request emergency approvals (EUAs) for those tests from the FDA. Then, on August 19, 2020, the Department of Health and Human Services (HHS) under former HHS Secretary Alex Azar announced that the Department had withdrawn all informal policy documents issued by the FDA regarding LDTs because the FDA had failed to act. concerned with notice-and-comment regulations. (See also a discussion of that promotion in our year-end post for 2020 devices, available here.) As a result, such products were no longer required to obtain an EUA or other non-emergency marketing authorization for non- COVID testing – to be obtained from the agency before commercial launch. Over the next 15 months, the FDA regularly declined to review EUA requests from LDT developers, prioritizing those products to focus on home collection kits and home testing, point-of-care testing for medical professionals, and high-throughput, widespread tests. That situation has led to much frustration among clinical labs seeking formal approval from the FDA for business, legal, or other reasons before launching a COVID-19 test.
However, on November 15 of this year, HHS pressed the reset button for the regulation of COVID-19 LDTs, allowing the FDA to require clinical labs to submit EUA requests for such tests. The same day, the FDA released a revised policy for testing for coronavirus disease-2019 during the public health emergency and an overarching EUA for serial testing using certain lab-developed diagnostic tests, and also updated nearly all of the FAQs related to COVID-19. -19 tests at. Importantly, in the revised COVID-19 testing policy and accompanying press release, the FDA emphasizes that any clinical lab currently offering a COVID-19 LDT must obtain an EUA to continue to conduct and commercialize such a product. test. Specifically, the revised COVID-19 testing policy states in the relevant section:
Diagnostic and serological tests on EUA-requested notification lists
For diagnostic or serological SARS-CoV-2 tests on any of the notification lists and for which an EUA request was made prior to the issuance of this updated guidance, the FDA does not intend to object to the onward distribution or offering of those tests over a period of time while the FDA reviews EUA requests for the tests, where:
1) The developer submitted its EUA request after February 1, 2021; or
2) The developer has submitted its EUA request by February 1, 2021 and the developer confirms to the FDA, within 45 calendar days from the date of issuance of this updated guidance, that:
a) the developer wants the FDA to continue to review its EUA request;
b) the EUA request is for the current version of the test; and
c) either the developer has no additional data to add, or the developer will submit updated information to the FDA within that 45 calendar day period….
If the FDA does not receive confirmation from a test developer who submitted its EUA request before February 1, 2021, confirming that the developer wants the FDA to continue reviewing its EUA request, the FDA plans to deny the review (or refuse further assessment when the assessment has already taken place) commenced) the EUA request.”
Laboratory serology tests on the Notified List and certain LDTs for which no EUA request has been made
Certain lab-developed serology tests are offered without FDA approval after the developer has notified the FDA as described in the previous version of this guidance. In addition, the FDA understands that some LDTs for SARS-CoV-2 will be offered without FDA authorization or submission of an EUA request following the August 2020 HHS announcement.
For such tests, the FDA does not intend to object to the continued offering of the tests, while the FDA reviews the EUA requests where the developer submits the EUA request to the FDA within 60 calendar days via email to CDRH- [email protected] as of the date of issue of this updated guidance.”
The FDA’s Nov. 15 press release also details the agency’s current focus areas for EUA reviews:
Diagnostic tests for the home and point of care that can be produced in large quantities;
High-volume, laboratory-based molecular diagnostic tests (and associated home sample collection kits) that enable sample pooling to increase throughput, asymptomatic screening and the detection of multiple respiratory viruses, or use other methods to increase capacity and accessibility;
Lab-based and point-of-care large-scale quantitative antibody testing; and
Tests submitted or supported by a U.S. government stakeholder, such as the National Institutes of Health’s Biomedical Advanced Research and Development Authority of Rapid Acceleration of Diagnostics.
The agency further recommends that developers of COVID-19 tests other than the types described above “consider seeking marketing authorization through traditional device assessment methods, such as 510(k) notification or The Novo classification.”
This sudden turnaround in policy and the re-imposition of regulatory restrictions and requirements will no doubt lead to a struggle by many clinical labs to re-contact the FDA and obtain authorization for their COVID-19 LDTs. Unfortunately, it appears that the agency is poised to deny the review or authorization of many currently unauthorized LDTs that do not fall within the FDA’s current review priorities.
It’s important to note that non-COVID-19 LDTs will remain under enforcement freedom after HHS’s withdrawal of the August 2020 policy, so it’s unclear if and how the FDA will use enforcement measures to penalize clinical labs that detect COVID-19 Continue to list LDTs without authorization. If the FDA ultimately rejects a majority of new LDTs because they fail to meet current EUA review priorities, the agency must be prepared for challenges from the clinical laboratory community. The ongoing regulatory and enforcement uncertainty in this area also increases the likelihood of potential Congressional action on comprehensive diagnostic reform legislation, enacted earlier this year in a bipartisan and bipartisan fashion. We will continue to monitor and report on these developments and how they may impact various stakeholders in the industry.
©1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC All rights reserved.National Law Review, Volume XI, Number 323