February 18, 2016- On Thursday, the Food and Drug Administration (FDA) announced a final order which will require manufacturers to submit a premarket approval (PMA) application for two types of metal on metal (MoM) total hip replacement devices:
hip joint metal/metal semi-constrained with a cemented acetabular component
hip joint metal/metal semi-constrained with an uncemented acetabular component
Here is the excerpt from the FDA announcement released today:
Given the known risks, the FDA believes that there is insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices. The agency has determined that these devices should remain Class III (higher risk) devices and PMA applications must be filed with the agency by May 18, 2016 if a manufacturer wants to continue marketing their MoM total hip replacement devices and/or market new MoM total hip replacement devices.
Manufacturers will be required to submit a PMA application that includes: (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.
Other FDA activities to date include:
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