WASHINGTON, June 29 -- Food and Drug Administration has issued a rule called: Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber.
The rule was published in the Federal Register on June 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber 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 medial knee implanted shock absorber. We are taking this action because we have determined that classifying the device into class II will...