FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; EAR, NOSE, AND THROAT DEVICES; CLASSIFICATION OF THE COOPERATIVE POWERED SURGICAL ASSIST DEVICE FOR ENT SURGERY

WASHINGTON, Sept. 10 -- Food and Drug Administration has issued a rule called: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery.

The rule was published in the Federal Register on Sept. 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery 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 cooperative powered surgical assist device for ENT surge...