FDA Launches Broad Effort To Rethink Regulation Of Implantable Devices

March 19, 2019
FDA is launching a broad effort to revisit implantable device regulation in light of a growing body of data that shows material in some devices could harm certain patients, according to outgoing agency chief Scott Gottlieb and device center head Jeff Shuren. FDA will seek help from outside experts, including at an advisory committee meeting this fall on metal in devices, to analyze whether material in breast implants, nitinol in devices, metal-on-metal total hip replacement products and animal material in...

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