GUDID 101: Everything You Need to Know About FDA’s Global Unique Device Identification Database

After years of planning, implementation, and compliance rollout dates, the FDA’s Global Unique Device Identification Database (GUDID) is fully operational. With this in mind, we thought it’d be a good idea to review the requirements for medical device manufacturers submitting their data to GUDID for the first time. 

This article will explain what the GUDID is, how it works, and what you can expect when preparing your submissions.

BONUS eBOOK: Click here to download your free PDF copy of our eBook, Ultimate Guide to UDI for Medical Devices.

What is the GUDID?

GUDID (pronounced “Good ID”) refers to the Global Unique Device Identification Database, a digital catalog created by the FDA to store detailed information on all medical devices with a unique device identifier (UDI). 

GUDID plays an essential role in FDA’s UDI system, serving as a central hub for critical device specifications such as manufacturer and production information, intended use, safety, and handling requirements.

GUDID was first introduced in 2013 as part of FDA’s UDI Final Rule, which requires a UDI for all devices marketed in the United States. Along with that regulation, FDA requires that manufacturers submit all UDI information to the GUDID, unless an exception is mentioned otherwise. How do GUDID and UDI work together?

What is a database without the data? GUDID is purpose-built to store, publish, and maintain the data obtained by these unique device identifiers. UDIs are a distinct numeric or alphanumeric code used to identify medical devices throughout healthcare supply chains. 

All UDIs contain two elements: 

• A device Identifier (DI), which identifies the manufacturer and the model/version of a device

• A production identifier (PI), which identifies one or more variable characteristics, such as manufactured date, expiration date, lot number, or serial number. 

When combined, the device identifier and the production identifier form the full-length UDI. The DI is always first and is followed by the PI if it has a value. This is often shortened to the formula of UDI = DI + PI.

FDA requires that device labelers submit the device identifier (DI) portion of the UDI, as it provides a method for obtaining key information stored in the database. GUDID does not require submission of the production identifiers (PIs). However, the appropriate entry would still contain references indicating the particular PI attributes contained in the label.

Looking to learn more about how UDIs work for your medical device company? Download your free copy of our new eBook, The Ultimate Guide to UDI for Medical Devices.

What are the benefits of GUDID?

Both GUDID and the UDI system it enables were established with the goal of creating a standardized method to identify and track all medical devices marketed in the US. In that regard, many of the benefits of the GUDID and UDI are one and the same, such as:

• Fewer medical errors caused by incorrect device identification

• Enhanced postmarket surveillance and effectiveness studies

• Improved adverse event reporting

• Faster and more efficient handling of recalls

But even beyond these obvious improvements, there are also major benefits in how GUDID itself is designed. 

3Who is required to submit data to GUDID?

FDA regulations state that GUDID submissions and general UDI compliance are the responsibility of the “device labeler,” which they define as: 

…Any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.

…in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.

What data should I submit to GUDID?

Overall, there are 57 attributes which GUDID requires for submissions to the database. For time and space constraints, I’ve broken these down into several essential categories: 

• Device Identifier information

• Commercial distribution

• Alternative identifiers 

• Customer contact information 

• DA codes and listing number 

• Manufacturing information 

• Device dimensions 

• Storage and handling

• Sterilization

For more information on which specific data categories are required, you can check out FDA’s guidance doc, or learn more in our comprehensive Ultimate Guide to UDI.

How do I prepare a GUDID submission?

FDA provides very in-depth information and helpful resources on the topic of preparing for GUDID submission. Even before preparing the submission, device labelers should be on top of the SOPs relating to organizing, collecting, and validating data. This preparation is extremely important, as GUDID depends on reliable, quality data to ensure the UDI system works appropriately. 

There are two methods that can be used for GUDID submissions:

1. Structured input which requires manual data entry on the GUDID Web Interface. This method is intended for low volume submitters.

2. Health Level 7 (HL7) Structured Product Labeling (SPL). This form of submission uses the FDA Electronic Submissions Gateway (ESG), which allows for submission via XML files and is intended for high volume submitters.

Keep in mind, multiple roles are often involved in the GUDID submission process. The guidelines indicate that any device may have multiple accounts, or outsource the work of documentation to an approved third-party.

The guidance also makes it a point to understand the roles associated with a GUDID submission. Each GUDID account is expected to have, at minimum:

• One Regulatory Contact

• One Labeler 

• One Coordinator

Lastly, each UDI labeler must obtain and provide its Data Universal Numbering System (DUNS) number and certification as part of the submission. That being said, the coordinator role is optional for submitters who are using the HL7 SPL submission route.

BONUS eBOOK: Click here to download your free PDF copy of our eBook, Ultimate Guide to UDI for Medical Devices.

GUDID goes hand-in-hand with Greenlight Guru’s QMS software

GUDID sets a standard that is meant to ensure medical devices marketed in the US are safe and effective. The bar has now been raised even higher, thanks to Greenlight Guru.

Our QMS software is the only end-to-end solution designed specifically for medical device professionals by medical device professionals. With the latest FDA and ISO industry best practices built into the system, Greenlight Guru will guide your medical device company throughout the entire product lifecycle.

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