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FDA Issues Final Order to Submit Premarket Approval for Metal-on-Metal Hip Implants

Metal Hip and Ball

The Food and Drug Administration issued a final order to manufacturers on February 18th requiring the submission of a premarket approval application (PMA) for two different types of metal-on-metal hip replacement devices.

The two devices that are in question are the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component.

The FDA believes that there is insufficient evidence and information to determine the safety and effectiveness of these devices and that they should remain Class III, or higher risk, devices.

Manufacturers must file PMA applications with the agency by May 18, 2016 in order to market their new, as well as existing, metal-on-metal hip implants.

According to the FDA, manufacturers are required to include the following in their PMA applications: "(1) any risks known, or that should be reasonably known, to the applicant; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought."

Learn more here.

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