Federal Register #FDA-2026-N-6733

FDA Classifies OTC SARS-CoV-2 and Diabetes Digital Therapeutic Devices as Class II with Special Controls

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a final order classifying two types of medical devices as Class II with special controls: - Over-the-counter SARS-CoV-2 test: - In vitro diagnostic device for detecting SARS-CoV-2 from clinical specimens - Intended for lay users in home or similar settings, without healthcare provider intervention - Special controls include: - Detailed labeling requirements - Clinical and analytical performance validation - Risk analysis and mitigation measures - Ongoing performance monitoring - Devices must meet premarket notification (510(k)) requirements - Diabetes digital behavioral therapeutic device: - Digital therapeutic device for diabetes management - Classified as Class II with special controls to ensure safety and effectiveness - No specific OEMs, vendors, part numbers, or purchase quantities are identified, as this is a regulatory classification action - The classification is designed to assure safety, effectiveness, and patient access while reducing regulatory burdens

Description

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). This classification provides reasonable assurance of safety and effectiveness and aims to reduce regulatory burdens, thereby enhancing patient access to innovative devices. The device is intended for use by lay users without healthcare provider intervention in home or similar settings. Special controls include detailed labeling, design verification, validation, and ongoing monitoring requirements to mitigate risks such as false results and incorrect test operation.

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