UDI Compliance Guide: Getting Your Device Listed in GUDID

What Is UDI?

The Unique Device Identification (UDI) system is an FDA requirement that every medical device carry a unique identifier that allows the device to be tracked throughout its distribution and use in healthcare settings. It was introduced under 21 CFR Part 830 and has been phased in since 2014, now applying to virtually all medical devices.

A UDI consists of two parts:

• Device Identifier (DI): A mandatory fixed portion that identifies the labeler and the specific version or model of a device
• Production Identifier (PI): A conditional, variable portion that identifies one or more of: lot/batch number, serial number, manufacturing date, expiration date, or distinct identification code for HCT/Ps

What Is GUDID?

The Global Unique Device Identification Database (GUDID) is the FDA's publicly accessible database of device identifier information. All labelers required to comply with UDI must submit device information to GUDID before or at the time of placing the device into commercial distribution in the U.S.

Who Must Comply?

UDI labeling and GUDID submission requirements apply to:

• All Class III devices (most stringent requirements, implemented first)
• All Class II devices including those exempt from 510(k)
• Class I devices (full compliance required)
• Devices licensed under the Public Health Service Act

Choosing an FDA-Accredited Issuing Agency

You must obtain your UDI from one of the FDA-accredited issuing agencies. Currently three are accredited:

• GS1 — Uses Global Trade Item Number (GTIN) format
• HIBCC — Uses Health Industry Bar Code (HIBC) format
• ICCBBA — Used primarily for blood, cellular therapy, and tissue products

Most manufacturers use GS1 due to its global adoption. You apply for a GS1 Company Prefix, which is then used to generate unique GTINs for each device version/model.

GUDID Submission: Step-by-Step

1. 1
   Register for a GUDID account Go to the GUDID portal (accessgudid.nlm.nih.gov) and register. You will need your establishment registration number and FDA credentials.
2. 2
   Obtain your UDI from an accredited issuing agency Apply with GS1, HIBCC, or ICCBBA. This involves paying a membership fee and receiving your company prefix or labeler code.
3. 3
   Populate the required device attributes GUDID requires extensive data for each DI, including device description, MRI safety, sterility, implantable status, single-use designation, and dimensions.
4. 4
   Submit and receive DI record Submit via the GUDID web interface or bulk upload. Once submitted and validated, your DI record is publicly searchable.
5. 5
   Apply UDI to device label The UDI must appear on the device label in both human-readable form (HIBC or linear bar code) and machine-readable form (typically a 2D Data Matrix barcode).

Common GUDID Submission Errors

• Submitting without first completing establishment registration
• Mismatched device description between 510(k) clearance and GUDID
• Incorrect MRI safety designation
• Missing or incorrect sterilization method information
• Not updating GUDID when device labeling changes