FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; ORTHOPEDIC DEVICES; CLASSIFICATION OF THE WEARABLE VIBRATION DEVICE FOR ORTHOPEDIC USE

WASHINGTON, Nov. 5 -- Food and Drug Administration has issued a rule called: Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use.

The rule was published in the Federal Register on Nov. 5 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use 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 wearable vibration device for orthopedic use. We are taking this action because we have determined that classifying the dev...