Labs prepare for December end of COVID test authorizations
CDC says emergency authorizations for COVID-19 diagnostic tests will end December 26, while some products may continue under federal transition policies.
A December 26 transition point
Clinical and public-health laboratories are being told to review whether the COVID-19 tests they use remain authorized only under emergency rules. A CDC laboratory advisory says the federal declaration supporting emergency use authorizations for in-vitro COVID-19 diagnostics will terminate on December 26.
The change follows a June determination by the Department of Health and Human Services that the circumstances supporting specified COVID-19 device declarations no longer exist. The 180-day transition period separates that decision from the effective termination date.
An emergency use authorization allows certain unapproved products, or unapproved uses of approved products, when statutory emergency criteria are met. It is not the same as traditional FDA clearance or approval.
Some tests may continue during review
FDA guidance describes circumstances in which the agency does not intend to object to continued distribution while a traditional marketing submission is under review. The manufacturer must submit an appropriate application that FDA accepts by December 26, among other conditions.
The Centers for Medicare & Medicaid Services says laboratories may continue using qualifying tests consistently with the former authorization, including the authorized setting, until the product's expiration date when FDA's transition policy applies.
That policy is not a blanket extension for every emergency-authorized test. CDC advises laboratories to contact manufacturers and confirm whether they plan to seek traditional FDA clearance and on what timetable.
What laboratories and patients should understand
If a manufacturer does not plan to pursue clearance, laboratories should prepare to move to a cleared or otherwise appropriately regulated assay. Inventory, validation, purchasing and staff procedures may need to be reviewed before the deadline.
The advisory is directed to laboratory and testing professionals. It does not tell patients to stop testing or discard a product solely because of the upcoming date. People using an at-home test should follow the product's current instructions, expiration information and FDA status.
The end of these declarations does not mean COVID-19 has disappeared, and it is separate from the public-health emergency that ended in 2023. The current action concerns the regulatory authority used for particular diagnostic tests and other devices.
A laboratory's transition plan may differ by product. Some manufacturers already have traditional authorizations, some may have applications under review and others may leave the market. Laboratories should document which assay, lot and regulatory pathway they use rather than assuming that all COVID-19 tests share the same status.
Facilities should also allow time for staff training and quality-control work when changing platforms. A regulatory deadline can therefore create operational work well before the final calendar date.
Laboratories should use FDA, CDC and CMS pages for product-specific and certification guidance. Patients with symptoms or questions about test results should consult a health professional rather than treating the regulatory transition as medical advice.