FDA Steps Up MoM Hip Oversight
February 26th, 2016 by Cutter Law
The FDA has announced that it’s stepping up oversight of metal-on-metal hip implants, in response to the steady stream of concerns about these medical devices.
Two types of MoM implants are affected by the new regulations:
- The hip joint metal/metal semi-constrained with a cemented acetabular component
- The hip joint metal/metal semi-constrained with an uncemented acetabular component
Manufacturers of these types of implants are now required to submit a Premarket Approval (PMA) application that includes the following:
- any risks known, or that should be reasonably known, to the applicant;
- the effectiveness of the device that is the subject of the application; and
- full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.
The FDA also decided that these types of MoM implants “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.”
The reason for the tightened regulation? The FDA believes 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.”
See the FDA’s February 18th Final Order here.
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