UDI

The U.S. Food and Drug Administration (FDA) has established a unique device identifier system(UDI) to facilitate the identification of medical devices. UDI guidelines specify proper usage of the unique device identifier in both human- and machine-readable forms and are intended to enhance the safety of healthcare workers, patients and caregivers. Manufacturers of medical devices are […]

A medical device is an instrument, appliance or piece of software designed by the manufacturer to be used for one or several of the following purposes:

The first phase of the FDA’s unique identification (UDI) system began on September 24, 2014. This marks an historic point in medical safety. The purpose of the UDI is to give the labels of medical devices a unique number or code that enables the device to be easily identifiable by healthcare workers, patients and caregivers.

The Food and Drug Administration (FDA) has set specific standards for the labeling of medical devices. It is vital that medical devices are labeled clearly and concisely to ensure that healthcare providers, patients and caregivers are able to understand the labels and use the devices in a safe and appropriate manner.