FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; CLASSIFICATION OF THE REAL-TIME ULTRASOUND ANATOMY VISUALIZATION AND LABELING DEVICE FOR ULTRASOUND GUIDED REGIONAL ANESTHESIA

WASHINGTON, June 1 -- Food and Drug Administration has issued a rule called: Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia.

The rule was published in the Federal Register on June 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia 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...