Federal Register #FDA-2026-N-7629

FDA Classifies Active Noise Attenuation System for Infant Incubators as Class II Medical Device

This FDA final order establishes a new regulatory classification for an active noise attenuation system designed for use in infant incubators. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Invictus Medical, Inc. (OEM of the Neoasis device) - Products/Services: - Active noise attenuation system for infant incubators - Example: Neoasis device by Invictus Medical, Inc. - No specific part numbers or quantities provided (regulatory notice, not a procurement) - Unique/Notable Requirements: - Device is classified as a Class II medical device under 21 CFR Part 880 - Subject to special controls, including: - Non-clinical performance testing - Software validation and verification - Electrical safety and electromagnetic compatibility testing - Biocompatibility evaluation - Specific labeling requirements - Classification based on De Novo request from Invictus Medical, Inc. - Aims to ensure safety, effectiveness, and facilitate patient access to innovative devices - No procurement or purchase is being solicited in this notice

Description

The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). This classification provides reasonable assurance of safety and effectiveness for the device. The device captures environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in healthcare environments. Special controls include non-clinical performance testing, software validation, electrical safety testing, biocompatibility evaluation, and specific labeling requirements. This action aims to enhance patient access to innovative devices by reducing regulatory burdens.

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