From the beginning of the pandemic, the FDA has had in place a procedure whereby laboratories were required to submit data and information on a specific COVID-19 test and, after review of the data and information, the Agency would authorize the use of that test under an EUA. The EUA would set forth conditions for marketing the test along with specifications as to, for instance, the technical validation and reliability of the test along with required labeling. To date, over 250 such tests have received EUAs.
In an announcement made during its October 7 “Virtual Town Hall Series,” (and in a change in one of the FAQs on its website), the FDA now says that since “we are currently in a different phase of the pandemic,” the Agency wants “to prioritize review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies, high-throughput, widely distributed tests).” As such, EUAs for LDTs for COVID-19 tests will no longer be reviewed. This applies to new EUAs and EUAs already in the pipeline. FDA said it will be informing the sponsors of EUAs already in the pipeline of this new change as soon as it generates a list of pending LDT EUAs.
The reason for this change is because of the recent directive from the Department of Health and Human Services which ruled that FDA cannot require EUAs for any LDTs unless there has first been notice-and-comment rulemaking. See our previous Alert on this HHS directive dated August 20. The HHS directive, with which FDA strongly disagreed, still allowed laboratories to submit EUAs for LDTs. Many laboratories wanted this because they would then receive immunity from liability under the Public Readiness and Emergency Preparedness (PREP) Act.
However, FDA has now decided that “in an effort to prioritize FDA resources for the greatest public health benefit considering the extent to which [the Agency] can use [its] authorities under the Food, Drug, and Cosmetic Act,” it will no longer review or even accept EUAs for COVID-19 LDTs. Thus the PREP immunity from liability will only apply to the 250+ tests that have already been authorized under EUAs – not to any new LDT tests for COVID-19.
In the same Virtual Town Hall meeting, the FDA discussed what will happen after the pandemic and how the tests will transition from EUA status to medical device premarket approval or clearance under the Agency’s existing 510(k) notification or de novo procedure. The Agency said that the same personnel who were reviewing EUAs will now work on the future premarket approval or clearance review.