Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens

What it does

The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the over-the-counter test to detect SARS-CoV-2 from clinical specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration's summary, as published in the Federal Register.

What changed in the regulation

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 866

Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).

Compared with

The Food and Drug Administration has published 100 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

This order is effective July 24, 2026. The classification was applicable on June 6, 2023.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2026-N-6733 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register