Federal Register #FDA-2026-N-4643

FDA Classifies Circulating Tumor Cell Enrichment Device as Class II Medical Device

This notice announces the FDA's regulatory classification of the circulating tumor cell enrichment device: - Issued by the Food and Drug Administration (FDA), Department of Health and Human Services - Circulating tumor cell enrichment device is now classified as a class II medical device with special controls - Device is used to enrich circulating tumor cells from the blood of cancer patients for diagnostic testing - Special controls include requirements for: - Labeling, device description, and intended use - Performance studies, design verification, and validation - No specific OEMs or vendors are named in this notice - This is a regulatory classification, not a procurement or award announcement - The action is intended to ensure safety and effectiveness, reduce regulatory burdens, and improve patient access to innovative devices

Description

The Food and Drug Administration (FDA) is classifying the circulating tumor cell enrichment device into class II (special controls). This device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing. The classification includes special controls such as labeling requirements, design verification, and validation studies to ensure safety and effectiveness. This action aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens.

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