- FDA has decided it will no longer review emergency use authorization submissions for COVID-19 laboratory developed tests to "make the best use" of agency resources and in the interests of public health.
- Tim Stenzel, director of FDA's Office of In Vitro Diagnostics and Radiological Health, made the announcement Wednesday during a weekly virtual town hall in which he quoted from the agency's updated FAQ page on SARS-CoV-2 testing that laid out the rationale for the decision.
- The move follows a shift by HHS in August when it said FDA would no longer require premarket review for LDTs but labs could voluntarily seek approval, clearance or emergency use authorization. Now, FDA is "declining to review EUA requests for LDTs," effectively shutting the door on new submissions as well as those already in the pipeline for review. The American Clinical Laboratory Association in a statement said FDA's announcement creates "unnecessary confusion."
HHS in August said it made the decision to rescind the established LDT policy as part of its ongoing review of "regulatory flexibilities" in place since late January's U.S. public health emergency declaration. However, in making Wednesday's announcement to no longer review EUA submissions for COVID-19 LDTs, Stenzel said the FDA and the country are in a "different phase of the pandemic" with respect to testing than previously, as many coronavirus tests are now authorized to be performed in laboratories.
In particular, FDA's updated page notes it has prioritized review of EUA requests for diagnostics meant to increase testing accessibility, such as point-of-care (POC) and at-home tests, as well as those designed to increase test capacity by maximizing the use of scarce lab supplies via high-throughput testing.
"FDA continues to prioritize review of EUA requests for POC tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests," according to the agency.
The American Clinical Laboratory Association, which represents some of the companies most impacted by the LDT policy changes, said FDA's decision to no longer review emergency use authorizations for lab-developed coronavirus tests is confusing in light of the fact that "many of the tests that have been granted EUAs for COVID-19 testing are innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity."
Julie Khani, ACLA's president, pointed out that "these are exactly the kinds of tests that FDA has stated it wants to prioritize" and argued that the agency should continue to allow labs to voluntarily submit EUAs for review and authorization per the HHS policy change issued in August.
ACLA, whose members include Quest and LabCorp, issued a statement in August in response to the HHS policy change arguing that labs providing testing services during the pandemic need "clarity and certainty" about how those services are regulated.
The lab group at the time said it is "critical that all laboratories developing and performing testing for COVID-19 — irrespective of the regulatory authorities under which they operate — have the appropriate expertise, equipment and training to develop valid tests and deliver the accurate and reliable results that patients and clinicians depend on."
HHS' August policy change reversed a long-established FDA approach and applies to all LDTs, not just COVID-19 diagnostics. A senior AdvaMed official speaking on background last month called the move "the wrong call." The medtech lobbying group is concerned that not all diagnostic test developers will be subject to the same standard of testing validation during the pandemic and beyond.