FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; CLASSIFICATION OF THE SPINAL IMAGING SYSTEM FOR NEURAXIAL PROCEDURES

WASHINGTON, Oct. 30 -- Food and Drug Administration has issued a rule called: Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures.

The rule was published in the Federal Register on Oct. 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 classif...