Manufacturers of two types of metal-on-metal (MoM) hip implants are now required to submit a PMA application. Today FDA issued the final rule for manufacturers of a hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component.
“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,” according to FDA’s website. The devices will remain Class III. The agency has given manufacturers a deadline of May 18,2016 for which they must file PMA applications that include known or reasonably known risks, device effectiveness, and reports of all clinical and non-clinical investigations about device safety and effectiveness.
The agency also outlined its efforts to ensure the safety of MoM hip implants, which includes:
- Working with MoM hip implant manufacturers to evaluate devices in an MRI environment, along with developing labeling to enable safe scanning of patients with these implants
- Encouraging metal ion test labs to participate in a trace element proficiency testing program
- Continual review of published medical literature, MDRs, and post-approval study data from registries worldwide
- Launch of International Consortium of Orthopaedic Registries
- Establishment of Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to discuss implant failure rates, metal ion testing, imaging methods, complications, patient risk, product labeling, and post-surgery considerations