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  1. Device Advice: Comprehensive Regulatory Assistance

Unique Device Identification System (UDI System)

News and Updates

On June 30, 2020, the FDA issued an immediately-in-effect guidance on its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining.  The guidance explains that, at this time, the FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), Direct Mark (21 CFR 801.45), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before September 24, 2022.

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.

Search AccessGUDID


Device Labelers: Comply with UDI Requirements

In general, the UDI final rule requires device labelers (typically, the manufacturer) to:

  1. 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.
  2. Submit device information to the Global Unique Device Identification Database (GUDID).

Start Here: UDI Basics


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.

Log In to GUDID




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