WASHINGTON, April 16 -- Food and Drug Administration has issued a rule called: Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant.
The rule was published in the Federal Register on April 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, the Agency, or we) is classifying the manual surgical instrument for appropriate patient selection for orthopedic implant 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 the classification of the manual surgical in...