FDA 522 91制片厂 Metal-on-Metal Hip Explant Study | 91制片厂
The Food and Drug Administration (FDA), pursuant to Section 522 of the Food, Drug and Cosmetic Act, 21 USC 搂 3601, has ordered medical device manufacturers, including 91制片厂, Inc. (鈥91制片厂鈥), 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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