Jul 13, 2021 Ezra Kelderman

What is the Global Unique Device Identification Database (GUDID)?

The U.S. Food and Drug Administration (FDA) created the Global Unique Device Identification Database (GUDID) as a labeling resource for medical device manufacturers worldwide. This resource is purpose-built for manufacturers that have obtained Unique Device Identifiers (UDI).

In short, the GUDID allows for improved tracking across all medical device types. The system includes critical information related to performance, production, packaging, and more. Without a centralized medical device database, conducting effective postmarket surveillance is virtually impossible.

Are you preparing to introduce your product to the market? Are you interested in accelerating the approval process?

Read on to learn more about the GUDID, including the submission process and UDI requirements.

What is the Global Unique Device Identification Database?

Building a market-ready life sciences product requires a careful analysis of both internal and external manufacturing processes, quality control procedures, and more.

For the best results, we recommend investing in a quality management system (QMS) from the outset. From improved document management to audit-ready reporting capabilities, quality teams rely on our QMS to design and distribute safe and effective products.

An investment here will help you ensure that your product meets or exceeds regulatory requirements enforced by the FDA prior to receiving approval for inclusion within the GUDID.

 

How to Obtain a Unique Device Identifier

According to Section 201(h) of the Food, Drug, and Cosmetic Act, a medical device is “intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” Additionally, this product category is limited to a device “which does not achieve its primary intended purpose through chemical action within or on the body of man or other animals.”

To obtain a UDI, manufacturers must first ensure that their product meets the FDA’s standard definition of a medical device. Applicants can also reference the FDA Product Classification Database to determine whether or not a product meets eligibility criteria under an existing device category.

unique-device-identification-databaseImage Source: The U.S. Food and Drug Administration

Finally, applicants must coordinate with an FDA-accredited issuing agency to obtain a UDI. At that time, the issuing agency will assign both a device identifier (DI) and production identifier (PI).

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How to Submit to the Global Unique Device Identification Database

After securing a UDI, the FDA requires medical device labelers to supply GUDID data using one of two application methods.

The first application method requires users to enter data manually through the online GUDID application. Before you begin, consult the GUDID User Manual for in-depth instructions related to the application and approval process.

The second application method requires applicants to submit XML files via the FDA Electronic Submissions Gateway. If you’re planning on going this route, start by requesting a GUDID account. From there, teams activate testing requirements outlined in the HL7 SPL Implementation Files.

Preparing for Global Unique Device Identification Database Submission

To the uninitiated, submitting to the GUDID can feel like a massive undertaking. However, the importance of the GUDID cannot be understated.

The UDI operates similarly to the barcode on a box of your favorite cereal. If a cereal is making consumers sick, regulatory bodies can quickly and easily identify the source of the issue (down to the production number) and alert the public through a recall.

The same can be done for medical devices. Activation of the UDI ensures that all medical devices can be tracked quickly and easily across the life sciences ecosystem, thereby improving health outcomes.

The UDI also underlines the importance of product quality. Investing in a modern QMS is one of the easiest things medical device manufacturers can do to ensure that products comply with all FDA regulations. Many of the world’s most successful life sciences organizations leverage our QMS to streamline document management, activate effective corrective and preventative (CAPA) measures, and more.

How does your life sciences company rate when it comes to quality management?

To find out, we recommend taking our free self-assessment

In just a few clicks, you’ll have all the information you need to identify the major root causes of any potential quality issues. 

Who knows? Completing this simple self-assessment could be the difference-maker in securing a compliant future!

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Published by Ezra Kelderman July 13, 2021