FDA considering medical tracking system.Under the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Amendments Act of 2007, which became law last September, the FDA is looking at requiring manufacturers of medical supplies to apply unique device identifiers (UDI (1) (Unified Display Interface) A digital interface from the United Display Interface SIG that is designed to replace the analog VGA interface common on CRTs and flat panel monitors. UDI is expected to provide backward compatibility with DVI and HDMI interfaces. ), such as RFID (Radio Frequency IDentification) A data collection technology that uses electronic tags for storing data. The tag, also known as an "electronic label," "transponder" or "code plate," is made up of an RFID chip attached to an antenna. technology, to individual items in order to track them along the supply chain. The law directs the FDA to establish a labeling system on medical devices ranging from latex gloves to infusion pumps. The UDI system must be able to identify the equipment and supplies throughout every stage of the supply chain, from distribution to use. The law does not mandate any specific technologies, nor does it specify a deadline, however, the FDA Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. is developing draft regulations to implement the new requirements. |
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