See Contact an FDA-Accredited Issuing Agency for details. To develop a UDI, device labelers must contact one of the issuing agencies accredited by the FDA. The following example of a UDI is for illustrative purposes onlyįor more information, see UDI Formats by FDA-Accredited Issuing Agency (January 27, 2017).ĭeveloping a UDI Using an FDA-Accredited Issuing Agency’s System In addition, the device labeler must present dates on device labels and packages in a standard format that is consistent with international standards and international practice (YYYY-MM-DD).
Machine-readable form that uses automatic identification and data capture (AIDC) technology.Īutomatic identification and data capture (AIDC): Any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.
The device labeler must provide the UDI in two forms on labels and packages:
#Barcode basics code
Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.Date a specific device was manufactured.Lot or batch number within which a device was manufactured.Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:.Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.In most instances, the labeler is the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.Ī unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following: The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler. Submitting information to the GUDID databaseĪ labeler is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.Understanding exceptions, alternatives, and time extensions.Meeting compliance dates and requirements.Developing a UDI using an FDA-accredited issuing agency’s system.