International Medical Device Regulatory Monitor
June 2011
| Vol.
19 No.
6
U.S. FDA Seeks Postapproval Hip Implant Studies
The U.S. Food and Drug Administration (FDA) is asking 21 devicemakers to conduct postapproval studies for their metal-on-metal (MoM) hip implants after reports of high ion concentrations of cobalt and chromium in the blood of patients using the devices.
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