FDA UDI Submission — GUDID Registration
FDA requires all medical device manufacturers to submit Unique Device Identifier (UDI) information to the Global Unique Device Identification Database (GUDID). LMG assists with GUDID account setup and UDI submissions.
UDI & GUDID Services -FDA Unique Device Identifier
The FDA has established a unique device identification system to adequately mark and identify medical devices through their distribution and use (in human-readable plain text and machine-readable formats like AIDC technology). A UDI is required on device labels and device packages, and in some cases on the devices themselves, unless there is an exception or alternative granted by the FDA. The UDI needs to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed between uses. The permanent UDI may be in plain text, AIDC technology, or both.
- The label of every medical device (including all IVDs) must have a UDI. Class I cGMP-exempt devices do not need to be labeled with a UDI.
- Every device package must have a UDI.
- Devices within co-packaged combination products that bear an NDC are required to bear a UDI on its label.
- Stand-alone software must bear a UDI on its label and device packages as well as on a startup screen.
The UDI is composed of two parts, Device Identifier (DI) and Product Identifier (PI).
DI (Mandatory, fixed portion of UDI)
| PI (Conditional, variable portion of UDI)
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The FDA has accredited three Issuing Agencies (GS1, HIBCC, and ICCBBA) that conform to international standards for assigning UDIs. Labelers can contact any accredited Issuing Agency to get the UDI. The fees for the UDI assignment vary by agency.
GUDID Submission:
The GUDID (Global Unique Device Identifier Database) is a database that contains device identification information. The GUDID contains only the DI portion of UDI. PI parts are not submitted to or stored in the GUDID.
The compliance dates for GUDID submissions are as follows:
(1) Class III medical devices, which include stand–alone software – September 24, 2014
(2) Implantable, life-supporting and life-sustaining devices, which include stand-alone software – September 24, 2015
(3) Class III reusable devices that are required to have UDI on the device itself, Class II devices – September 24, 2016
(4) Class II reusable devices that are required to have UDI on the device itself, Class I, which includes stand-alone software, and Unclassified devices – September 24, 2018
(5) Class I reusable devices that are required to have UDI on the device itself – September 24, 2020
(6) For Class I and unclassified devices which require to bear UDI – September 24, 2018
GUDID Account Setup
Setup of your FDA GUDID account — the required first step for all device manufacturers submitting UDI data to FDA. Includes account registration and system configuration.
GUDID Device Record Submission
Complete preparation and submission of your device records to the GUDID database — including all required DI and PI data elements for each device version/model.
UDI Label Compliance
Verification that your device label carries the UDI in both human-readable form (HRI) and machine-readable form (AIDC) — in HIBC or GS1 format as required by FDA.
GUDID Updates
When device information changes — new versions, labeling updates, discontinuation — GUDID records must be updated. We manage ongoing GUDID record maintenance.
How It Works
Frequently Asked Questions
What is a UDI?
A Unique Device Identifier (UDI) is a unique numeric or alphanumeric code that consists of a Device Identifier (DI) — specific to the device version/model — and a Production Identifier (PI) — specific to the production unit.
What is GUDID?
The Global Unique Device Identification Database (GUDID) is the FDA database that holds information about each UDI. Device labelers must submit device records to GUDID for all devices requiring UDIs.
Which devices require UDIs?
All medical devices distributed in the U.S. require UDIs. Class III devices had the earliest compliance dates; Class I and II devices followed. Combination products may also require UDIs.
What UDI issuing agencies does FDA accept?
The FDA has accredited three Issuing Agencies (GS1, HIBCC and ICCBBA) that conform to international standards to assign UDI.
Need Help with UDI Submission?
LMG assists medical device manufacturers with GUDID setup and complete UDI submission.
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