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FDA toughening rules on all-metal hip implants
Modern Healthcare

The Food and Drug Administration has proposed new regulations that would require the manufacturers of metal-on-metal hip implants to test for safety and effectiveness in response to the devices’ high failure rates. The FDA’s proposed order would mandate that manufacturers submit a premarket approval application or a notice of completion of a product development protocol for metal-on-metal total hip replacement systems and resurfacing hip systems within 90 days of the final order.