Tuesday, November 10, 2026

For physician offices that perform respiratory testing, December 26, 2026 is more than a date on the calendar. It is the day the federal declarations supporting emergency use authorization (EUA) of certain COVID-19 medical devices, including in vitro diagnostic tests used to detect or diagnose SARS-CoV-2, are scheduled to terminate.3 On June 29, 2026, the U.S. Department of Health and Human Services (HHS) Secretary determined that circumstances no longer exist to justify those declarations, and HHS published the termination notice on July 2, 2026.3 FDA states that, on December 26, 2026, the COVID-19 device EUAs currently listed on its website will no longer be in effect.4

Physician offices should identify tests that have an EUA designation, confirm each product’s status, and adjust their purchasing and inventory appropriately. The transition does not mean practices must immediately stop using EUA-designated products already purchased or stocked. Rather, manufacturers cannot sell or ship EUA products as of December 26, 2026. Products already stocked at distributor warehouses or in healthcare facilities may continue to be sold and used until the expiration date stated on the product labeling.

Understanding what changes in December

An EUA is an emergency authorization issued under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).3 An EUA is not the same as FDA clearance or approval, and it is designed for emergency circumstances only.

A 510(k) clearance is one traditional premarket pathway. Through a 510(k), FDA determines that a device is substantially equivalent to a legally marketed predicate device for its intended use.4 Other traditional pathways may be appropriate for different devices, such as De Novo authorization or premarket approval. For physician offices, the key point is not to determine which pathway a manufacturer should pursue, but to verify that each test used after December 26 has an appropriate non-emergency regulatory status and is used according to its current labeling.

This December 2026 termination should not be confused with the end of the federal COVID-19 public health emergency. The public health emergency declared under section 319 of the Public Health Service Act expired on May 11, 2023, but FDA explains that the end of that public health emergency did not automatically terminate device EUAs issued under section 564 of the FD&C Act.4 Those device EUAs remained in effect until the separate EUA declarations for affected COVID-19 medical devices are terminated.

Start with a testing-menu and inventory review

A smooth transition begins with a complete inventory of all COVID-19 diagnostic products in the medical practice. That includes stand-alone COVID-19 assays as well as combination assays that detect SARS-CoV-2 along with influenza or other respiratory pathogens.

The next step is to determine which products rely solely on an EUA and which have traditional FDA marketing authorization. Because product names, formats, and packaging can be similar across generations of a test, practices should verify status using FDA resources, the current instructions for use, and product-specific information from the manufacturer or distributor.4 A general statement that a company offers a cleared test is not enough; the office should confirm the exact product and configuration it intends to order and use.

HHS provided 180 days’ advance notice before the December 26 termination date. The Federal Register notice explains that this period is intended to provide sufficient time for appropriate product disposition and transition planning.

Build a solid transition plan

Once EUA products are identified, practices can work to develop an operational transition plan. The goal is not to discard usable products on the deadline, but to manage purchasing, stocking, staff readiness, and replacement-product implementation in a controlled way.

The timing will differ by practice. A high-volume urgent care or primary care site may use remaining EUA-designated inventory quickly, while a smaller office may need to slow or stop reordering earlier to avoid stock that cannot reasonably be used before expiry.

Regulatory status is one consideration but not the only one. The replacement must also fit the practice’s patient population, testing workflow, and documentation requirements.

For physician office laboratories (POLs), the review should also include laboratory-specific elements such as CLIA status, quality-control procedures, staff training, competency documentation, and written test procedures.

Prepare the people and systems, not just the supply shelf

Before adopting a replacement product, the practice should update any standard operating procedure, test menu, standing order, staff training document, or testing workflows that name the outgoing product. Training should address the replacement test’s intended use, specimen collection, step-by-step procedure, timing, control requirements, valid and invalid results and limitations. Staff should understand not only how to run the test, but also how the labeling describes appropriate use and interpretation.

A 510(k) cleared option for the transition

For practices transitioning from an EUA-authorized COVID-19 or COVID-19/influenza combo test, the OSOM® COVID-19/Flu A&B Combo Test is an 510(k) cleared, CLIA-waived option to consider.1 The test is a lateral-flow immunochromatographic which differentiates COVID-19, influenza A, and influenza B from one anterior nasal swab with results in 15 minutes.1, As with any diagnostic test, limitations should remain visible in protocols and staff education.

This type of product integration should be viewed as one part of a broader transition plan. A 510(k) cleared replacement can support continuity when practices are ready to move to a 510(k) cleared product, but implementation still requires review of the current instructions for use, updates to procedures and documentation, and staff readiness before the product becomes part of routine point-of-care testing.

Use the transition to strengthen the testing program

Preparation should begin with the products already on the shelf and extend through the systems that support ordering, testing, reporting, and patient communication. By inventorying current tests, verifying regulatory status, managing remaining EUA-designated inventory through labeled expiration dates, selecting cleared replacement products early, and preparing staff before workflow changes occur, practices can maintain testing continuity while moving beyond emergency authorization in a planned and responsible way.

References

1 Sekisui Diagnostics, LLC. (2026a, August). OSOM® COVID-19/Flu A&B Combo Test instructions for use (Catalog No. 1099; Document No. 3617-0).

2 U.S. Food and Drug Administration. (2023, March 27). Transition plan for medical devices issued Emergency Use Authorizations (EUAs) related to Coronavirus Disease 2019 (COVID-19): Guidance for industry, other stakeholders, and Food and Drug Administration staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-related-coronavirus-disease

3 U.S. Department of Health and Human Services. (2026, July 2). Termination of three declarations authorizing emergency use of medical devices during the COVID-19 pandemic. Federal Register, 91, 40544. https://www.federalregister.gov/documents/2026/07/02/2026-13373/termination-of-three-declarations-authorizing-emergency-use-of-medical-devices-during-the-covid-19

4 U.S. Food and Drug Administration. (2026, August 11). COVID-19 emergency use authorizations for medical devices. https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/covid-19-emergency-use-authorizations-medical-devices