News and Updates
On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued the final guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). This guidance details the FDA’s recommendations for the form and content of the UDIs that must appear on devices according to the UDI Rule. It is intended to assist labelers and FDA-accredited issuing agencies in complying with UDI labeling requirements.
The FDA has extended alternatives UDI-A160001 and UDI-A160002, under which certain non-prescription, over the counter devices intended to be sold exclusively through retail establishments may continue to bear a Universal Product Code (UPC) as their device identifier. The alternatives expire on September 24, 2023.
For details on these two alternatives, see the FDA Decisions section on the UDI Exceptions, Alternatives, and Time Extensions page.
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
Search the AccessGUDID Database
AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, and premarket submission numbers. AccessGUDID is available for anyone, including patients, care givers, health care providers, hospitals, and industry.
Device Labelers: Comply with UDI Requirements
In general, the UDI final rule requires device labelers (typically, the manufacturer) to:
- Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency’s UDI system, on device labels, device packages, and in some instances, directly on the device.
- Submit device information to the Global Unique Device Identification Database (GUDID).
Device Labelers: Submit Data to GUDID
The FDA provides device labelers with two options for submitting data to GUDID: manual data entry using the GUDID web application (for entering data for one device at a time) and HL7 SPL submission via FDA Electronic Submissions Gateway (for bulk uploads). For details on each option, see Submit Data to GUDID.