Product Liability Update - December 2013


by Kelly MacHenry

Many medical devices will soon carry a unique identity code, under a new rule recently published by the U.S. Food and Drug Administration (FDA). The FDA refers to this as the Unique Device Identifier (UDI) rule.

A medical device is a medical or health machine, implant, instrument or other similar article. It is intended for use in diagnosing, treating or preventing disease in humans or other animals. Medical devices act through physical, mechanical or thermal methods. This distinguishes them from pharmaceuticals and drugs, which act through chemical or metabolic methods. Some of the most common types of medical devices are artificial hips and knees, pacemakers, breast implants, coronary stents, artificial eye lenses and internal bone fixation hardware.

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