FDA 522 911勛圖 Metal-on-Metal Hip Explant Study | 911勛圖
The Food and Drug Administration (FDA), pursuant to Section 522 of the Food, Drug and Cosmetic Act, 21 USC 禮 3601, has ordered medical device manufacturers, including 911勛圖, Inc. (911勛圖), to conduct post market surveillance studies of their metal-on-metal hip implants.
Part of the post-market surveillance includes the study of explanted retrievals when made available after medically necessary surgical intervention. Below you will find copies of all the pertinent letters and forms for this activity.
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