United States: FDA Launches Medical Device Database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its "Unique Device Identification System," or "UDI System," first created in September of 2013 and required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July of 2012. (See also §519(f) of the FD&CA or 21 U.S.C. § 360i) The Global Unique Device Identification Database (Or GUDID, pronounced "Good ID"), is a searchable Web site containing a listing of all Unique Device Identifiers, or UDIs. The UDI system is designed to simplify the identification of certain medical devices used in the United States and regulated by the FDA.

Currently, manufacturers mark their medical devices using their own systems of lot, batch, catalogue, and/or model numbers. These numbers often mean very little to anyone but the manufacturing company, and as a result, it can be very difficult to identify individual devices. Similarly, confusing manufacturer-created marking schemes can make it incredibly difficult for hospitals or other organizations that purchase and implant these medical devices to file accurate and precise adverse event reports, or to alert the manufacturer to an issue. These issues with product identification also extend to the ability for individuals, health care providers and industry organizations to identify product classes, individual models and devices that may have significant issues.

The implementation of the UDI marking system is designed to solve these issues. UDIs will be used to specifically identify a device using both a plain text representation as well as a barcode or similar computer-readable format, and are designed to address a specific set of issues with current medical device marking and tracking systems.

  1. Reduce Medical Errors– The link between UDIs and entries in the GUDID will allow physicians and health care providers the ability to rapidly and efficiently identify a device, its key attributes and its proper intended use. This can prevent errors related to the inadvertent misuse of a device when confused with devices of similar name or appearance.
  2. Simplification of Device Use Information into Data Systems – Using UDIs, as opposed to the myriad of naming schemes used by device manufacturers today, will aid in proper inventory management, pre-surgery device identification, and proper device recommendations by physicians.
  3. More Rapid Identification of Medical Devices with Adverse Events– With the now mandatory inclusion of UDIs within Adverse Event Reports submitted to the FDA by treating physicians, hospitals or device manufacturers, the FDA and manufacturers will be better able to aggregate, analyze and take appropriate measures to identify problem devices, identify risky procedures and develop proper solutions to minimize risks.
  4. Provide for More Rapid Recalls – Similarly, the use of UDIs will allow manufacturers to better identify product batches or models that have defects, the patients in whom they have been implanted, and will facilitate more efficient and effective recalls, minimizing risks to affected patients.
  5. More Effective FDA Communications – Currently, the FDA must rely on the previously described manufacturer-specific naming and marking schemes to identify medical devices when discussing them in Rules, Guidances or other publications. By instead referring to UDIs, the FDA can better and more accurately communicate new actions and policy to manufacturers, health care providers and patients.
  6. Better Identification of Similar Devices – Though not called out by the FDA specifically, the new GUDID system also appears to provide a valuable resource for device manufacturers seeking to identify devices to fulfill the "substantial equivalence" requirements of 510(k) premarket notifications.


A UDI is composed of two parts:

  • Device Identifier (DI) – A unique numeric or alphanumeric code specific to a device version or model.
  • Production Identifier(s) (PI) – Numeric or alphanumeric codes that identify production information for a device and can include the following:

    • The lot or batch number;
    • The serial number;
    • The expiration date;
    • The date the device was manufactured;
    • For a Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) regulated as a device, the distinct identification code that allows the manufacturer to associate the HCT/P to the donor.

Therefore, UDI = DI + PI.

UDIs are created based on international standards for unique identification. Private organizations, called "Issuing Agencies", are accredited by the FDA to operate a system for the issuance of UDIs based on these standards.

The Launch of GUDID

The GUDID launched on May 4th, in an early beta format, is the backbone that enables the entire UDI system to function. As the backbone of the UDI system, the GUDID is the go-to resource for health care providers, device manufacturers and patients when dealing with UDI-marked medical devices. Each GUDID entry provides the following information:

  • Device Identifier (DI) Information – This is the most basic identifying information identifying the device. It includes the DI number, brand and model numbers, manufacturer and basic description.
  • Device Characteristics – This is basic information about the device, and will vary based on the nature of the device identified. From prescription status, to MRI concerns, whether it is part of a kit, its proper storage and sterilization requirements, or if it is a biological product derived from human tissue, the Device Characteristics identify those aspects of the device most useful in identifying the device. This section will not necessarily contain safety information or warnings.
  • Device Status – This section identifies whether the device is currently being distributed commercially, as well as the beginning and end dates of that distribution.
  • Alternative and Additional Identifiers – This section describes whether the device bears any manufacturer-specific identifiers like lot, batch, model or category numbers or codes.
  • Customer Contact – This section is designed to provide customers and consumers with a method of contacting the device company with questions or issues. However, in our brief survey of the site, few of the UDI entries had this section populated with manufacturer contact information.

While much of the information provided in the GUDID is similar or identical to the device's label contents, they serve slightly different purposes. While both are aimed at properly identifying the device, the GUDID information is not focused on patient education or warning. In later posts to this blog, we will discuss some of the exemptions to the UDI system requirements and corresponding GUDID listings.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions