USA: PMAs obligatory for Metal-On-Metal Hips
On February 18, 2016, the FDA – US Food and Drug Administration issued a final order “Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems”. Manufacturers have time until May 18, 2016 to either submit a premarket approval application (PMA) for their metal-on-metal (MoM) hip products or take them off the market.
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.
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.
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