The U.S. Food and Drug Administration (FDA) has finalized UDI guidance content requirements and form for unique device identifiers (UDIs), after five years from its first drafted release. The guidance covers two types of UDIs, including automatic identification and data capture (AIDC) as well as readable plain-text form, and the usage of data delimiters and order that the data is presented in for UDI plain-text form. The FDA stated that the guidance is describes, “the requirements for, and FDA’s recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule,” and is intended for agencies that are accredited by the FDA as well as labelers.
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