FDA aims to clamp down on metal hip implants
The FDA prepares to issue new regulatory guidelines on metal-on-metal hip implants, potentially requiring companies with devices already on the market to submit new applications with clinical evidence of safety and effectiveness.
The FDA is expected to propose a new rule that would alter the regulation of metal-on-metal hips, placing the devices firmly in a higher-risk classification that requires more stringent FDA review.
Once finalized the rule may require that companies such as Johnson & Johnson (NYSE:JNJ), Smith & Nephew (FTSE:SN, NYSE:SNN), Biomet and others resubmit FDA applications for the metal hip implants they already sell in the U.S., or else remove those devices from the market.
The proposed rule is set to be issued today, but may not be finalized for another year, buying orthopedic device companies some time to offer suggestions on the proposal and prepare for a possibly unfavorable outcome, according to a New York Times report.