Opportunity
Federal Register #FDA-2026-N-9902
FDA Classifies Cooperative Powered Surgical Assist Device for ENT Surgery as Class II with Special Controls
Buyer
Food and Drug Administration
Posted
September 10, 2026
Identifier
FDA-2026-N-9902
NAICS
339112
The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final order establishing regulatory requirements for cooperative powered surgical assist devices used in ear, nose, and throat (ENT) surgery. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Galen Robotics referenced as a device sponsor for a similar platform - Products/Services Requested: - Cooperative powered surgical assist device for ENT surgery - Intended to facilitate precise and stable positioning of surgical instruments while maintaining surgeon's direct physical control - Unique or Notable Requirements: - Device classified as Class II with special controls - Special controls include: - Simulated-use testing - Non-clinical performance testing - Software verification and validation - Sterility and biocompatibility requirements - Shelf life validation - Specific labeling requirements - Classification aims to ensure safety and effectiveness and reduce regulatory burdens to enhance patient access - No procurement or award is announced; this notice sets regulatory standards for the device type
Description
The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II with special controls. This device facilitates ENT surgical procedures by assisting with precise and stable positioning of an instrument while maintaining the surgeon's direct physical control. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The special controls include requirements for simulated-use testing, non-clinical performance testing, software validation, sterility, biocompatibility, and labeling.