2026-22181·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures

Final RuleEffective

Published: Oct 30, 2026
Effective: Oct 30, 2026
Citation: 91 FR 68460
Docket: Docket No. FDA-2026-N-12255
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) has re‑classified the spinal imaging system used for neuraxial procedures—such as epidural and spinal anesthesias—from a lower risk category to a Class II medical device. Class II devices must meet specific “special controls” that address safety and performance, which the FDA has now defined for this technology. The change is intended to ensure a reasonable level of safety and effectiveness while also streamlining the pathway for innovative products, making them more readily available to patients. This final rule was issued by the Department of Health and Human Services, specifically the FDA, and it applies to manufacturers, importers, and distributors of spinal imaging systems intended for use in neuraxial procedures. Health‑care providers who use these devices and patients receiving them are indirectly affected, as the new classification sets the standards manufacturers must meet before the devices can be marketed. The rule became effective on October 30 2026, the same day it was published in the Federal Register (91 FR 68460). Because this is a final amendment, there is no further public comment period; the FDA will now incorporate the special‑control requirements into its regulatory code. Manufacturers must comply with those controls for any new or existing devices, and the FDA will continue routine oversight to ensure the devices remain safe and effective.

AI-generated summary — verify against the Federal Register text.

Official abstract

The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the spinal imaging system for neuraxial procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.