On February 18, 2016, the FDA issued a final order which will require the submission of premarket approval (PMA) applications for metal-on-metal (MoM) total hip replacement devices, which are hip implants where the “ball and socket” of the device are both made from metal. The devices included in this order are:
- Hip joint metal/metal semi-constrained with a cemented acetabular component.
- Hip joint metal/metal semi-constrained with an uncemented acetabular component.
The Agency decided to increase its regulatory requirements for these devices after determining that, “given to the known risks, 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.” As such, FDA also stated that it will continue classifying these devices as high risk, and they will therefore remain class III medical devices.
Manufacturers are required to submit PMAs by May 18, 2016 in order to continue selling applicable devices that are currently being marketed, and/or to begin marketing new MoM total hip replacement devices. In its final order, the Agency stated that the following information must be included in PMA submissions sent to the FDA:
- Any known risks, or that should be reasonably known, to the applicant
- The effectiveness of the device that is the subject of the application
- Full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.
For additional information, view the final order issued by the FDA.
Do you have a medical device subject to these regulatory requirements? We can help ensure that your medical device, as well as any other FDA-regulated product, is compliant with all requirements. To learn more about our services and how we can help you, contact us today.