Federal Register #FDA-2026-N-6238

FDA Classifies Point-of-Care SARS-CoV-2 Detection Device as Class II (Special Controls)

This notice announces the FDA's regulatory classification of a simple point-of-care device for direct detection of SARS-CoV-2 viral targets: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Device Classification: - Simple point-of-care device for direct detection of SARS-CoV-2 from clinical specimens - Classified as Class II (special controls) medical device - Intended Use: - Detection of SARS-CoV-2 viral targets in respiratory specimens in near-patient settings - Regulatory Requirements: - Subject to premarket notification (510(k)) - Must comply with special controls, including: - Device labeling requirements - Performance characteristics and validation - Use of FDA-cleared sample collection devices - Risk mitigation procedures - Comprehensive device description - No specific OEMs or vendors are named - No procurement, solicitation, or award is being announced; this is a regulatory classification action - The classification is intended to ensure safety, effectiveness, and facilitate patient access while reducing regulatory burdens

Description

The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings into class II (special controls). This classification aims to ensure the safety and effectiveness of the device while improving patient access by reducing regulatory burdens. The device is subject to premarket notification requirements under section 510(k) of the FD&C Act. The order is effective June 11, 2026, with the classification applicable from March 8, 2023.

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