Opportunity
Federal Register #2026-22181
FDA Class II classification and special controls for spinal imaging systems used in neuraxial procedures
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 30, 2026
Identifier
2026-22181
The FDA issued a final classification order for spinal imaging systems used in neuraxial procedures, establishing them as Class II medical devices subject to special controls. - Government authority: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), including the Center for Devices and Radiological Health (CDRH). - OEM named: IntuiTap Medical, Inc., which requested De Novo classification for its VerTouch Spinal Imaging Device. - Device type: A sensor and software system intended to assist in identifying the interspinous space during neuraxial procedures. - Requirements: Special controls address clinical and non-clinical performance testing, human factors, software verification and validation, electrical, mechanical, thermal, and electromagnetic safety, biocompatibility, sterility, and labeling. - The device type remains subject to FDA premarket notification requirements. - This is a regulatory classification action, not a solicitation for products or services; no quantities, part numbers, or contract period are specified.
Description
The FDA classifies the spinal imaging system for neuraxial procedures as a class II medical device subject to special controls. The device is identified as a sensor and software system used to assist in identifying the interspinous space for neuraxial procedures. The order establishes special controls addressing clinical and non-clinical performance, human factors, software, safety and compatibility, biocompatibility, sterility, and labeling. The classification was applicable January 19, 2024, and the final order is effective October 30, 2026.