FDA Gives Home COVID Tests a Permanent Class II Address

FDA has given the over-the-counter SARS-CoV-2 test a permanent regulatory address. A final order published 24 July 2026 classifies the device type into Class II with special controls, adding a new entry — 21 CFR 866.3984 — to the Code of Federal Regulations. The order looks procedural, and it is: no new test is authorized by it, and nothing changes for a product already on the market. What it does is close out, for this device type, the improvisational path that pandemic-era diagnostics have run on for three years, and open the ordinary one.

De Novo now, classification order later

The sequence is standard, even if the gap between its two steps is not. Under section 513(f)(2) of the FD&C Act, a genuinely novel, low-to-moderate-risk device with no predicate to cite can seek a De Novo request instead of the default Class III designation. FDA grants the request, the device reaches the market, and — eventually — the agency issues a classification order in the Federal Register that writes the new device type into 21 CFR, complete with the special controls that stand in for a predicate's track record. That second step is what happened on 24 July: three years after the type's first De Novo grant took effect, on 6 June 2023, FDA has formally codified “over-the-counter test to detect SARS-CoV-2 from clinical specimens” as its own generic device type.

One category, two technologies

The classification is written around use setting and user, not chemistry. A lateral-flow antigen test read by a consumer at home and a molecular nucleic-acid test processed in a compact home instrument both qualify, provided they are intended for lay users, without a healthcare provider, to aid diagnosis of SARS-CoV-2 infection from a clinical specimen. That technology-neutral framing is deliberate: it means the special controls FDA has now fixed in place — the performance, labeling, and validation expectations that substitute for Class III review — travel with the use case, not with any one manufacturer's design choices.

What changes for the next applicant

• Before this order: a manufacturer building a new over-the-counter SARS-CoV-2 test without its own De Novo grant to cite had no predicate to point to for a 510(k) — the pathway a first-of-kind device is built to avoid.
• After this order: 21 CFR 866.3984 is itself a citable predicate. A new entrant can file a 510(k) demonstrating substantial equivalence to the classified type, instead of assembling its own De Novo submission from scratch.
• Already-cleared devices are unaffected — the order does not revoke or modify any existing authorization; it generalizes the pathway for what comes next.
• The pattern is repeating by test type: near-patient point-of-care devices (21 CFR 866.3982) and prescription serology tests (21 CFR 866.3983) went through the same two-step De Novo–then–classification sequence earlier this year.

None of this is enforcement or a safety finding — it is FDA closing the loop on the regulatory architecture that pandemic-era diagnostics were built under. For sponsors watching the over-the-counter diagnostics space, including those tracking the classification precedent set in FDA's recent CMC readiness work for accelerated development, the practical takeaway is narrow but real: the 510(k) door for this device type is now open, and a De Novo filing for a substantially equivalent product is no longer the only way in.