Federal Register #FDA-2026-N-4270

FDA Classifies Radiation Therapy Marking Device as Class II with Special Controls

The Food and Drug Administration (FDA) has issued a final order regarding the classification of a radiation therapy marking device: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Medical Precision B.V. is referenced as the requester for De Novo classification of the Comfort Marker 2.0 device - Products/Services Requested: - Radiation therapy marking device (no procurement or purchase is being solicited) - Device defined as a powered device that delivers a permanent or temporary colorant to the skin to guide radiation therapy - Unique or Notable Requirements: - Device is classified as Class II (special controls) under 21 CFR Part 892 - Special controls include: - Design verification and validation - Biocompatibility evaluation - Sterilization validation - Performance testing - Labeling requirements - Software validation - Excludes devices with reusable or reprocessed needles and those intended for diagnostic, therapeutic, or aesthetic use - Action aims to ensure safety and effectiveness, reduce regulatory burdens, and improve patient access to innovative devices - No procurement, solicitation, or award is announced in this notice

Description

The Food and Drug Administration (FDA) is classifying the radiation therapy marking device into class II (special controls). This device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. The classification includes special controls to ensure safety and effectiveness, such as design verification, labeling requirements, and performance testing. 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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