Unique Device Identification System (UDI System)
News and Updates
On July 22, 2022, the FDA posted the final guidance: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices. This final guidance describes the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The update to this guidance reflects the finalization of the draft guidance "Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices", which was issued October 14, 2021, and following the consideration of public comments. This final guidance describes the FDA's compliance policy regarding GUDID submission requirements for certain Class I devices considered consumer health products. Additionally, the FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022. I/LS/LS devices, including Class I I/LS/LS devices, are already expected to comply with GUDID submission requirements. This new date provides a 75-day extension of an existing FDA compliance policy published in the July 2020 version of this guidance.
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.