Spine instrumentation and the FDA: what spine surgeons should know.
The regulatory process is long, frustrating, and expensive in many regards. It is also unavoidable for companies wishing to participate in the medical industry. Surgeons who choose to become involved in leading technologies will find themselves inevitably surrounded by FDA issues. The most efficient and effective means of dealing with this situation is to cooperate with the device manufacturers, who are subject to these regulations, and "do it right." Surgeons, patients, and manufacturers are the ultimate winners if the regulatory process is used appropriately.
Buckman
P M
PM
Buckman Company, Inc., Martinez, California 94533.
D013502:General Surgery; D006801:Humans; D009984:Orthopedic Fixation Devices; D010820:Physicians; D019736:Prostheses and Implants; D013131:Spine / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration