Artificial joints are medical devices, which must be cleared or approved by the FDA before they can be marketed in the United States. In addition, FDA permission is required before a company can test a new or redesigned prosthesis in human studies. The data gathered in these studies, which take place in specific hospitals, may then be used to support a company's application for marketing its prosthesis to surgeons and hospitals throughout the United States.
What does the agency look for before clearing a prosthesis for marketing? "It has to be proven safe and effective," says Barbara Zimmerman, chief of the FDA's orthopedic devices branch. "FDA assures safety and effectiveness using different means depending on the risks of a particular device and the technology that it presents."
For devices with a history of safe and effective use, frequently those using established technology, the FDA relies on a set of general controls to determine which devices can be marketed, says Zimmerman. "These general controls are augmented with special controls such as standards or standard test methods.
"For devices involving new uses or advanced technology, FDA often requires that a particular device be demonstrated to be safe and effective through clinical trials," she says.
"All You Need to Know About Joint Surgery," © 2002, Arthritis Foundation