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.
Metal-on-metal hip implants currently sit in a sort of regulatory gray area, considered in some respects to be high-risk devices, but regulated as moderate-risk devices for the purposes of FDA review. Companies seeking the FDA's nod to introduce a new MoM hip to the U.S. market have only to demonstrate that the new implants are "substantially equivalent" to ones already on the market, skipping the clinical trials that are required of the higher-risk category of devices.
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