Shoulder, knee implant reclassification petitions being crafted by orthopedic coalition.
This article was originally published in The Gray Sheet
Executive Summary
KNEE, SHOULDER IMPLANT DOWNCLASSIFICATION PETITIONS are under development by a coalition of orthopedics groups including the American Academy of Orthopedic Surgeons, the American Orthopedic Association, the American Society for Testing and Materials, the Orthopedic Surgical Manufacturers Association and the Orthopedic Research Society. Informally known as the "Device Forum," the group hopes to present preliminary drafts of the petitions -- which will seek to move certain knee and shoulder implants from Class III to Class II -- to the FDA Office of Device Evaluation's Orthopedic Devices Branch at the end of April.
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