Federal Register #FDA-2026-N-9908

FDA Classifies Three Medical Devices as Class II with Special Controls

This FDA regulatory notice announces the classification of three medical devices into Class II with special controls: - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health - OEMs and Vendors Mentioned: - BlueWind Medical Ltd. (Implanted Tibial Electrical Urinary Continence Device) - Xenex Disinfection Services, Inc. (Whole Room Microbial Reduction Device) - Products/Devices Classified: - Cooperative powered surgical assist device for ENT surgery - Facilitates precise and stable instrument positioning for ENT procedures - Implanted tibial electrical urinary continence device (BlueWind Medical Ltd.) - Implanted, externally powered device for tibial nerve stimulation to treat overactive bladder symptoms - Whole room microbial reduction device (Xenex Disinfection Services, Inc.) - Device for microbial reduction in hospital rooms - Unique or Notable Requirements: - Devices must meet special controls for safety and effectiveness, including performance, biocompatibility, sterility, shelf life, electromagnetic compatibility, software validation, and labeling - Classification aims to reduce regulatory burden while ensuring patient safety - No procurement or solicitation is included; this is a regulatory classification notice, not a request for bids or proposals.

Description

The FDA is classifying the implanted tibial electrical urinary continence device into class II with special controls to ensure safety and effectiveness. This device is an implanted prescription device that receives power from an external source to provide electrical stimulation of the tibial nerve near the ankle. It is intended for treating overactive bladder symptoms such as urge urinary incontinence, urgency, frequency, and nocturia. The classification aims to enhance patient access by reducing regulatory burdens while maintaining safety standards.

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