Federal Register #FDA-2026-N-6712

FDA Classifies SARS-CoV-2 Serology Test and Breast Implant Suction Retrieval System as Class II Medical Devices

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, announces the classification of two medical devices as Class II with special controls: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Devices Classified: - SARS-CoV-2 serology test - Part number: 866.3983 - In vitro diagnostic device for detecting antibodies to SARS-CoV-2 - For prescription use only; not for diagnosing acute infection or donor screening - Subject to special controls and premarket notification (510(k)) requirements - Breast implant suction retrieval system - Part number: 878.4675 - Device for breast implant suction retrieval - Classified with special controls to ensure safety and effectiveness - Unique Requirements: - Compliance with special controls as outlined by the FDA - Devices must be labeled for prescription use - Intended to reduce regulatory burdens and enhance patient access to innovative devices - No specific OEMs, vendors, or purchase quantities are identified in this notice.

Description

The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). This classification provides reasonable assurance of safety and effectiveness and aims to enhance patient access by reducing regulatory burdens. The special controls for the device type are identified in the order and will be part of the codified language for classification. The device is for prescription use only and subject to premarket notification requirements under section 510(k) of the FD&C Act.

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