High-Risk Implants Need Toughest FDA Review, Group Says

Law360, New York (April 19, 2013, 6:45 PM EDT) -- The group Consumers Union urged the U.S. Food and Drug Administration on Thursday to require all high-risk implantable medical devices, including metal-on-metal hip implants and surgical mesh, to undergo the agency's most stringent review process before hitting the market.

The request came in a letter to the agency in support of its January proposal to require makers of metal-on-metal hip implants to file a premarket approval application or a product development protocol, which are pathways to FDA approval for medical devices that pose the greatest risk...
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