Nobody is revoking these tests. On December 26 the three declarations that let the FDA authorize COVID-19 devices at all are terminated, and every emergency use authorization resting on them stops being effective. No test fails a review. The ground under it is removed, and the product goes with it.
The Secretary of Health and Human Services signed that determination on June 29, and the notice published in the Federal Register on July 2. It runs two pages. It opens a 180-day window that HHS called a sufficient period for disposition of the product, which is the formal phrase for getting inventory back off the shelves. Companies still selling a COVID-19 test under an EUA have 124 days of that window left.
What the date actually terminates
Three declarations end at once. The first, issued February 4, 2020, covered in vitro diagnostics for detecting SARS-CoV-2. The second, from March 2 of that year, covered personal respiratory protective devices. The third, March 24, covered medical devices broadly, including the improvised products hospitals pressed into service that spring. Ventilators, blood purification systems, remote patient monitors, and screening tools all rode in on that third one.
An emergency use authorization does not outlive the declaration that created it. FDA states it plainly: on the effective date, the COVID-19 EUAs for devices listed on its site will no longer be in effect. FDA will publish separate notices for the individual authorizations, but those follow a decision already made. And the schedule has been readable for years. FDA floated the 180-day period in a draft guidance in December 2021, asked industry whether it was long enough to avoid shortages, took the comments, and kept it in the final guidance it issued in March 2023.
The companies that already moved
More than fifty COVID-19 tests now hold traditional marketing authorization, a count the termination notice cites as part of its own reasoning. Most came through 510(k). A few came through De Novo. BioFire's Respiratory Panel 2.1 was granted De Novo in March 2021, Ortho-Clinical's two antibody assays in May 2023, Quidel's Sofia 2 antigen test that December. Each of those created a classification where none existed, so the company that went first wrote the terms everyone behind it would be measured against.
Writing those terms starts with how you define the product, and that is the decision I have lived. At Galen we took a 510(k) rejection and came back through De Novo, and the device on the bench never changed. What changed was the definition. A remote-control telemanipulator has to argue it is equivalent to something already cleared. A surgeon-access stabilizer has to prove what it claims about access. The second framing was defensible with engineering and usability evidence. The first one never was, and no amount of paperwork was going to rescue it.
The conversions are still landing. ACON cleared a combined RSV, flu, and COVID rapid test on July 10 this year. Visby cleared a flu and COVID test in May, Assure Tech and CorDx in June. Companies are clearing the permanent bar four and five months out from a deadline that has been on the calendar since 2023.
The two standards were never the same standard
Here is the gap that made these transitions take years. To issue an EUA, FDA had to find it reasonable to believe a product may be effective, weighed against an emergency. To clear or approve that same product through the normal route, FDA has to find a reasonable assurance of safety and effectiveness. One is a judgment made under time pressure about a plausible benefit. The other is a finding about the device itself, and it holds after the emergency ends.
That gap is about evidence, and no filing strategy closes it. A diagnostics company that started assembling its clinical and analytical package in 2023 is on FDA's list today. A company that treated the EUA as a finished product and kept shipping now has 124 days to produce data it never collected.
Dave's take
An emergency authorization was always a lease, not a deed, and the lease had a termination clause anyone could read. I say the same thing about patents: the grant is a clock, and the only thing a clock is good for is building something durable before it runs out. The founders on FDA's list this morning spent those years building. The ones who did not are about to find out that a market position you never earned on the permanent standard was inventory with an expiration date.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →