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FDA Wants Feedback On How To Properly Label Devices With Risky Materials

The US agency wants stakeholders to chime in on what information should be included in product labels to notify patients about potential side-effects of medical device materials, without being too burdensome for manufacturers.

Entrance to FDA headquarters in Maryland

The US Food and Drug Administration says it wants feedback from stakeholders about how to tell patients and providers about potential risks from materials used in medical devices. The agency, however, is wary of developing any requirements that would be considered too burdensome for manufacturers.

The FDA in recent years has come under criticism from patient advocacy groups for being too lax about allowing potentially dangerous devices on the market, and for not better informing...

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