Contains Nonbinding Recommendations 
 
Global Unique Device Identification 
Database (GUDID)
 
 
Guidance for Industry and  
Food and Drug Administration Staff  
 
 
Document issued on June 27, 2014.  
 
The draft of this document was issued on September 24, 2013. 
 
This document supersedes Global Unique Device Identification Database 
(GUDID), June 11, 2014. 
 
 
For questions for the Center for Devices and Radiological Health regarding this document contact 
UDI Regulatory Policy Support, 301-796-5995, email: udi@fda.hhs.gov. For questions for the Center 
for Biologics Evaluation and Research regarding this document, contact the Office of 
Communication, Outreach and Development at 1-800-335-4709 or 240-402-7800. 
 
 
 
 
 
 
 
            U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
    Center for Biologics Evaluation and Research 
1 
  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2013-D-0117. Comments may not be acted upon 
by the Agency until the document is next revised or updated. 
 
 
Additional Copies 
 
CDRH  
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1831 to 
identify the guidance you are requesting. 
 
CBER  
Additional copies of this guidance document are also available from the Center for Biologics 
Evaluation and Research (CBER), Office of Communication, Outreach and Development,  
10903 New Hampshire Ave, Bldg. 71, Room 3128, Silver Spring, MD 20993, or by calling 1-800-
835-4709 or 240-402-7800, by email ocod@fda.hhs.gov, or from the Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.h
tm.   
2 
  Contains Nonbinding Recommendations 
 
Table of Contents 
1  INTRODUCTION .............................................................................................................................................. 4 
2  UNIQUE DEVICE IDENTIFIER (UDI) ............................................................................................................ 5 
3.1  GUDID KEY CONCEPTS ............................................................................................................................................ 7 
3.1.1  GUDID Account ........................................................................................................................................... 7 
3.1.2   Device Identifier (DI) Record ..................................................................................................................... 13 
3.1.3   DI Record Life-Cycle .................................................................................................................................. 18 
3.2  GUDID MODULES ................................................................................................................................................. 21 
3.2.1   GUDID Web Interface ............................................................................................................................... 22 
3.2.2   HL7 SPL Submission ................................................................................................................................... 29 
3.2.3   Search/Retrieval of Device Information.................................................................................................... 30 
4   GUDID SUBMISSIONS AND 21 CFR 11 REQUIREMENTS ...................................................................................... 31 
5   CONCLUSION ...................................................................................................................................................... 31 
APPENDIX A  GUDID PACKAGE INFORMATION EXAMPLES ....................................................................................... 32 
EXAMPLE 1: UNIT OF USE DI + ONE PACKAGE LEVEL ............................................................................................................ 32 
EXAMPLE 2: DI ON INDIVIDUAL DEVICE + MULTIPLE PACKAGE LEVELS .................................................................................... 34 
APPENDIX B  GUDID DATA ELEMENTS REFERENCE TABLE ................................................................... 36 
APPENDIX C  UDI FORMATS BY FDA ACCREDITED ISSUING AGENCY .................................................. 37 
APPENDIX D  GUDID ATTRIBUTES MAPPED TO A FICTITIOUS MEDICAL DEVICE LABEL ............... 38 
ABBREVIATIONS & ACRONYMS ....................................................................................................................... 39 
  
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  Contains Nonbinding Recommendations 
 
 
Global Unique Device Identification Database 
(GUDID) 
 
Guidance for Industry and Food and Drug 
Administration Staff 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
1  Introduction  
 
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, 
effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical 
devices, the nations food supply, cosmetics, dietary supplements, and products that give off radiation; and for 
regulating tobacco products.  
 
Section 226 of the FDA Amendments Act (FDAAA) of 2007 and Section 614 of the FDA Safety and 
Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), 
which directs the FDA to promulgate regulations establishing a unique device identification system for medical 
devices along with implementation timeframes for certain medical devices. The Unique Device Identifier (UDI) 
Proposed Rule was published on July 10, 2012, followed by an amendment, published on November 19, 2012, 
modifying the implementation time frame for certain devices.  In developing the proposed rule, we solicited 
input from a variety of stakeholders (e.g., manufacturers, global regulatory bodies, the clinical community, 
patient advocates) to ensure that as many perspectives were incorporated as possible.  The UDI Final Rule was 
published on September 24, 2013. UDI initiatives are also underway globally -- the European Commission 
released a framework for a UDI System in April 2013; the International Medical Device Regulators Forum 
(IMDRF) UDI Work Group issued a guidance document on UDI in December 2013. 
 
This document is primarily intended for device Labelers1, and provides information necessary for submitting 
data to the Global Unique Device Identification Database (GUDID). A draft version of this document was 
                                                           
1  The UDI Final Rule (http://www.fda.gov/udi ) defines labeler as any person who causes a label to be applied to a device with the 
intent that the device will be commercially distributed without any intended subsequent replacement or modification of the label; 
and, any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially 
distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact 
4  Contains Nonbinding Recommendations 
 
released on September 24, 2013 with a 60 day comment period, which ended on November 25, 2013. More 
than 300 comments were received from 21 entities.  In order to provide labelers access to the latest information 
as soon as it is available, and address sections that received the most comments and questions, sections of this 
document were previously finalized and released on June 11, 2014. This current iteration of the document 
finalizes the remaining sections and incorporates sections finalized earlier, in order to provide one complete 
and final document.  
 
Please note that database enhancements may continue to improve user experience, build in better validation 
rules, and make other necessary changes as we learn from the initial roll-out and implementation. We intend 
to periodically update this document to reflect system changes and enhancements. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. 
Instead, a guidance describes the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in 
Agency guidances means that something is suggested or recommended, but not required.  
 
2  Unique Device Identifier (UDI)  
 
The unique device identifier (UDI) should be created and maintained by device labelers based on global 
device identification standards managed by FDA-accredited Issuing Agencies2,3.  As of the publication date of 
this document, we have accredited three issuing agencies  GS1, HIBCC and ICCBBA. The UDI Formats by 
FDA Accredited Issuing Agency4 document, provides the standard UDI formats for the three issuing agencies. 
 
A UDI is required to appear on the label of every medical device, and every device package, unless excepted. 
This includes combination products that contain a device constituent part; convenience kits; in vitro diagnostic 
products; human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated as devices; and 
stand-alone software5. The UDI is composed of two parts: 
  Device Identifier (DI) - a mandatory, fixed portion of a UDI that identifies the labeler and the specific 
version or model of a device; and 
  Production Identifier(s) (PI)  a conditional, variable portion of a UDI that identifies one or more of the 
following when included on the label of a device, unless excepted:  
  the lot or batch number within which a device was manufactured;  
o
  the serial number of a specific device;  
o
  the expiration date of a specific device;  
o
  the date a specific device was manufactured;  
o
  and, for an HCT/P regulated as a device, the distinct identification code required by 21 CFR 
o
1271.290(c)6.   
                                                                                                                                                                                                                        
information for, a person who distributes the device, without making any other changes to the label, is not a modification for the 
purposes of determining whether a person is a labeler.  
2 Refer to the UDI Final Rule (http://www.fda.gov/udi ) for details on issuing agencies and their role in UDI assignment. 
3
See 21 CFR 801.57(c ) and visit http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm161456.htm for 
information regarding continued use of National Health Related Items Code (NHRIC) and National Drug Code (NDC).  
4 See UDI Formats by FDA-Accredited Issuing Agency document, available on www.fda.gov/udi  
5 Stand-alone software version number may be represented as Lot or Batch number production identifier. 
6 21 CFR 1271.290(c) requires that the manufacturer of each HCT/P assign and label the HCT/P with a distinct identification code that 
allows the manufacturer to relate the HCT/P to the donor and to all records pertaining to the HCT/P.  The distinct identification code 
may take the form of a donation identification number, serial number, lot number, or a combination of these production identifiers.  In 
5  Contains Nonbinding Recommendations 
 
 
Therefore, UDI = DI + PI. 
 
The DI will serve as the primary key and can be used to look up information about the device in the GUDID. 
 
Any identifiers beyond those specified in this document are outside the scope of the FDA regulated UDI. 
 
Note that the UDI of a class I device is not required to include a PI. Further, a class I device that bears a 
Universal Product Code (UPC) on its label and device packages is deemed to have met the UDI labeling 
requirements. Finally, Class I devices that FDA has by regulation exempted from the good manufacturing 
practice requirements (other than recordkeeping requirements) do not need a UDI. See 21 CFR 801.30(a)(2). 
 
Labelers are required to enter the DI along with additional device attribute information to the GUDID, as 
specified in the final rule, unless subject to an exception or alternative. While we expect GUDID DI 
submissions to occur as soon as practicable, for device versions or models initially entering commercial 
distribution, the DI records for such devices should be in the published state no later than fifteen calendar days 
from the initial date that version or model is introduced into commercial distribution.  
 
3  Global Unique Device Identification Database (GUDID)  
 
The GUDID serves as the repository of key device identification information.  The GUDID contains ONLY the 
DI, which serves as the primary key to obtain device information in the database.  PIs are not submitted to or 
stored in the GUDID; the GUDID contains only production identifier flags to indicate which PI attribute(s) are 
on the device label, unless excepted.  
 
The GUDID includes all of the data elements required by 21 CFR 830.310.  The GUDID also includes certain 
ancillary administrative data used to develop and maintain the GUDID and to facilitate integration of DI 
information with internal FDA systems.  A complete list of GUDID data elements and descriptions are provided 
provided in the GUDID Data Element Reference Table7. For those data attributes in the GUDID that appear in 
medical device labeling, the attribute values submitted to GUDID should be consistent with their representation 
in the labeling.  See example in Appendix D, which maps some GUDID attributes to a fictitious device label. 
 
The design principles guiding GUDID development includes the following: 
 
  Standards-based submission with two options: 
  Structured input via the GUDID Web Interface  requires manual data entry and is geared for 
o
low volume submitters. 
  Health Level 7 (HL7)8 Structured Product Labeling (SPL)9 submission via the FDA Electronic 
o
Submissions Gateway (ESG)10  allows for submission via xml files and is geared for high 
volume submitters. 
                                                                                                                                                                                                                        
the GUDID, labelers of HCT/Ps regulated as medical devices should select the appropriate type of production identifier that appears 
the label of the device.  
7 See GUDID Data Elements Reference Table, available on www.fda.gov/udi  
8  HL7 is a standards development organization, whose mission is to provide messaging standards for interoperability, exchange, 
management, and integration of data that supports clinical patient care and the management, delivery, and evaluation of healthcare 
services. Visit http://www.hl7.org for more information. 
9 Structured Product Labeling (SPL) is a HL7 standard for the exchange of product information using extensible markup language 
(XML). 
6  Contains Nonbinding Recommendations 
 
  Standards-based data repository with controlled vocabularies including: 
  Dun & Bradstreet (D&B) Number (DUNS)11  
o
  Global Medical Device Nomenclature (GMDN)12 
o
  FDA Product Codes  
o
  Free and public access to the device information in GUDID via public search; download capability is 
planned for the future. 
 
  3.1  GUDID Key Concepts 
 
The next few sections present an overview of GUDID key concepts such as GUDID account and user roles, the 
device identifier record, and the device identifier record life-cycle.  Note that these concepts apply to both 
GUDID submission options  Web Interface and HL7 SPL xml file submission. 
 
 
      3.1.1  GUDID Account 
 
Labelers that are required to submit information to the GUDID should first request a GUDID account.  This 
section presents an overview of the GUDID account, the user roles, preparatory steps to obtain a GUDID 
account, how to request a GUDID account and how to manage account changes. The structure of the GUDID 
Account and the different user roles are depicted in Figure 1.  
                                                                                                                                                                                                                        
10 FDA ESG enables the secure submission of regulatory information. For more information, please visit: http://www.fda.gov/esg    
11 Data Universal Numbering System or D-U-N-S Number is a unique nine-digit identification number assigned and managed by Dun 
& Bradstreet to business entities. For more information, visit 
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm  
12 Global Medical Device Nomenclature (GMDN) is system of internationally agreed descriptors used to identify medical device 
products and is managed by the GMDN Agency. Visit: http://www.gmdnagency.com/default.aspx 
7  Contains Nonbinding Recommendations 
 
 
Figure 1: GUDID Account and User Roles 
8  Contains Nonbinding Recommendations 
 
A Labeler Organization may have one or more GUDID accounts. 
  GUDID utilizes DUNS numbers to enable identification of labeler organizations using a uniform standard 
and process. The DUNS number is an important component of the FDA Unique Facility Identifier System, 
along with a Geocode, which specifies the exact location of the facility (GUDID does not collect 
Geocodes). 
  Labelers should manage their company information via the DUNS number and GUDID pulls company 
name and address from the D&B DUNS database. 
  Each GUDID account is identified by the Organization DUNS Number.  
  This DUNS number represents the labelers view of the highest corporate level in the labeler 
o
organization; it may be the headquarters DUNS number, or the parent DUNS number for the 
labelers included in the GUDID account. 
  Please ensure that the name and address in the D&B DUNS database is accurate, as this number 
o
is used to identify the labeler organization in GUDID; company name and address are pulled 
from the DUNS database.  
  The organization DUNS number serves as the primary key for the GUDID account. Once used, 
o
it cannot be reused to create another GUDID account. 
  The organization DUNS number can be used as a Labeler DUNS number (see below).   
o
 
  Each account should have only one Regulatory Contact.  
  As noted in 21 CFR 830.320(a), a Regulatory Contact13: 
o
  Is the individual who serves as the point of contact to us on matters relating to the 
identification of medical devices marketed by the labeler; he/she is responsible for ensuring  
the labeler organization meets GUDID submission requirements. 
  Is the highest point of contact for the labeler organization, i.e., we may first contact the 
GUDID Coordinator for issues related to the data submitted to GUDID, and if the issue is 
not resolved, bring it to the attention of the Regulatory Contact. 
  Does not have functional user role in GUDID i.e, no user-name or password to access 
GUDID.  
  Can also serve as GUDID Coordinator and Labeler Data Entry user, if so desired (see 
below); both of these user roles would have a separate user name and password to access 
GUDID.  
  You may choose to use a third-party to serve as the Regulatory Contact for GUDID as described 
o
in 21 CFR 830.320(a); you should inform us of your intent to do so during the GUDID account 
request process via a letter on your company letterhead, signed by a responsible official from 
your organization.  
 
  Each GUDID account should have one or more labelers, identified by Labeler DUNS numbers. 
  Device information would be submitted for the Labelers identified in the GUDID account. 
o
  Each device record should be associated to a Labeler DUNS number, and is used to pull the 
o
labeler company name and address from the D&B DUNS database.  
  To ensure data consistency the company name associated to the Labeler DUNS number should 
o
match the company name that appears on the device label. Ideally the address associated with 
the DUNS number should also match the address on the device label, but since address is not 
displayed to the GUDID public user, this is not a requirement; however, labelers are encouraged 
                                                           
13 GUDID Account user contact information provided is for FDA internal use only; not available via GUDID public search and 
retrieval. 
9  Contains Nonbinding Recommendations 
 
to work towards this model for new products and when making changes to existing products as 
appropriate. 
  Organization DUNS number can be used as Labeler DUNS number. 
o
  Labeler DUNS number, once used, cannot be reused in any other GUDID account. 
o
 
  Each GUDID account should have one or more Coordinators13. 
  Each Coordinator would be assigned one or more Labeler DUNS numbers, in a given GUDID 
o
account. 
  Coordinators manage the GUDID account for their designated Labeler DUNS numbers. 
o
Responsibilities should include: 
  Create Labeler Data Entry (LDE) User account(s) (see below). 
  Assign Labeler DUNS number(s) to LDE(s). 
  Create LDE User role for a third-party (see below), if so desired. 
  Serve as Regulatory Contact, if so desired. 
  Serve as LDE user, if so desired; separate user name and password is provided for the LDE 
user role. 
  Serve as the first point of contact and respond to FDA inquiries related to GUDID data 
quality, incorrect or inconsistent data, and other submission/data specific questions. 
  A given Labeler DUNS Number can be assigned to more than one Coordinator (see Figure 1, 
o
Labeler DUNS Number 3 is assigned Coordinator 1 and Coordinator 2). The Coordinators 
would then share responsibility for DI records associated to that Labeler DUNS number. 
 
  Each GUDID account should have one or more LDE Users13.  
  Each LDE user is assigned one or more labelers, identified by Labeler DUNS numbers, in a 
o
given GUDID account. 
  An LDE user: 
o
  Is responsible for data entry, submission, and management of device identification 
information for their designated Labeler DUNS into the GUDID. 
  Can serve as Regulatory Contact, if so desired. 
  Can serve as Coordinator user, if so desired; separate user name and password is provided 
for the Coordinator user role. 
  A given Labeler DUNS Number can be assigned to more than one LDE user. The LDE users 
o
would then share responsibility for DI records associated to that Labeler DUNS number. 
 
The labeler has the option to designate third-party submitters for GUDID submissions. A third-party submitter 
is a company/individual (contractor, vendor) authorized to submit GUDID information on behalf of the labeler. 
The third-party may submit data on behalf of the labeler, but the labeler is ultimately held responsible for the 
information submitted to GUDID. 
  Each GUDID account may have zero or more third-party submitters. 
  Web Interface submission option  a third-party may use the GUDID Web Interface to enter data for the 
labeler. You, the labeler, may choose to request the Coordinator user role for the third-party (request 
sent to FDA, see section 3.1.1.2); you may provide the third-party with LDE user access. 
  HL7 SPL submission option  the third-party may: 
  Provide software solution/tool to generate the HL7 SPL xml file; you, the labeler, would then 
o
submit the file via the FDA ESG. or, 
  Provide end-to-end solution to the labeler, i.e., generate the HL7 SPL xml file, and submit it via 
o
the FDA ESG for the labeler. In order to enable a third party to submit to GUDID via the ESG, 
the following should be noted: 
10  Contains Nonbinding Recommendations 
 
  You, the labeler, should identify the third-party by providing the third-party DUNS number 
during your GUDID account request. The third party is associated to your labeler account. 
By identifying the third-party, you are authorizing the third-party to submit GUDID 
information on your behalf. 
  GUDID HL7 SPL submissions sent via the ESG by a third party not associated to a GUDID 
account are rejected. 
 
Note that GUDID Regulatory Contact, Coordinator and LDE user contact information provided by labeler 
organizations is used for internal FDA purposes only; not available via GUDID public search and retrieval. 
 
Submission of device information to GUDID requires establishment of a GUDID account, regardless of the 
submission option chosen via Web Interface or via FDA ESG as HL7 SPL xml files.  Please note that the 
GUDID account is not by submission type, i.e., a separate GUDID account is not needed for each submission 
option. The account identifies the labeler in GUDID and enables submission of device information via both 
options. See section 3.1.1.2 for detailed description of the account establishment process.  
 
Search and retrieval of GUDID information does not require a GUDID account. 
 
3.1.1.1  Preparatory Steps Prior to Requesting a GUDID Account 
 
Prior to requesting a GUDID account, labeler organizations are encouraged to ensure the following: 
  Familiarize yourself with the two submission options available  GUDID Web Interface and HL7 SPL 
xml file submission. 
  Identify the DUNS Numbers to be used for your GUDID account. 
  If your company does not have a DUNS number, you can obtain one free of charge from D&B.  
o
Please note that this may take up to 30 business days; please plan accordingly.  
  Expedited options to obtain a DUNS number are available for a nominal fee.  
o
  Please visit 
o
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm  for 
more information. 
  Ensure the company name and address associated to the DUNS number is correct; if any changes are 
necessary, please update your information in the D&B DUNS database before requesting a GUDID 
account. 
  Identify individuals for the various user roles in GUDID -- Regulatory Contact, Coordinator(s) and LDE 
user(s).  
  Note that the one individual can take on multiple GUDID user roles. 
o
  If you plan to use a third-party to serve as the Regulatory Contact for GUDID as described in 21 
o
CFR 830.320(a), please inform us of your intent to do so during the GUDID account request 
process via a letter on your company letterhead, signed by a responsible official from your 
organization.  
  Identify an individual to request the GUDID account; and, once the account is established, to manage 
all account changes. 
  Identify third-party submitters, if applicable. 
  Obtain third-party DUNS number after ensuring that they have verified their information in the 
o
DUNS database as accurate. 
 
11  Contains Nonbinding Recommendations 
 
3.1.1.2  GUDID Account Request Process 
 
Once the necessary information is gathered, a GUDID account request may be submitted to us. Visit 
http://www.fda.gov/udi for information on how to submit the request. 
 
The following information should be provided when requesting a GUDID Account: 
  Labeler Organization DUNS Number  this DUNS number represents the labelers view of the highest 
corporate level in the labeler organization; it may be the headquarters DUNS number, or the parent 
DUNS number for the Labelers included in the GUDID account.  
  Labeler Organization Name  this is used for verification purposes only; GUDID obtains company 
name and address from the D&B DUNS database. 
  Regulatory Contact information  name, email, phone, physical address.  
  Labeler DUNS for the GUDID Account  as indicated earlier in Section 3.1.1, the company name 
associated to the Labeler DUNS number should match the labeler name as it appears on the device 
label; ideally, the company address associated to the DUNS number should also match the address on 
the label, but since address is not displayed to the GUDID public user, this is not a requirement for data 
consistency. 
  Coordinator Information:  
  Contact information  name, email, phone 
o
  List of Labeler DUNS that is the responsibility of the Coordinator; if there are multiple 
o
Coordinators, please specify the DUNS that each Coordinator is responsible for in GUDID. 
  Third-party DUNS numbers, if applicable 
  Indicate the preferred submission option  Web Interface or HL7 SPL or both 
  HL7 SPL submitters should first complete testing as specified in the HL7 SPL Implementation 
o
specification, prior to submitting to production GUDID. Therefore, HL7 SPL submitters are first 
provided with a test GUDID account. 
 
Note that GUDID Regulatory Contact, Coordinator and LDE user contact information that you provide is used 
for internal FDA purposes only; not available via GUDID public search and retrieval. 
 
Once we receive the GUDID account request, the information is reviewed. We may contact the individual 
requesting the account with any questions such as discrepancies with labeler company name and address 
associated to DUNS numbers, third party information etc.. Once all issues are resolved, we create the GUDID 
account using the GUDID Web Interface; the Coordinator receives login information and a temporary password 
via a system generated email. 
 
Each GUDID account will have, at a minimum:  
  one Regulatory Contact  
  one Labeler DUNS number 
  one Coordinator  for submitters who are using the HL7 SPL submission option, the Coordinator user 
is optional. 
 
Once a GUDID account is created: 
  The Web Interface submitter may login and begin using GUDID14. 
                                                           
14 For detailed information on logging in and using GUDID for each user role, please refer to the Global Unique Device Identification 
Database (GUDID) User Manual, available at -- 
12  Contains Nonbinding Recommendations 
 
  Coordinator may access the system via their temporary login and password to create LDE Users 
o
  Coordinator should have the following information to create an LDE user account: 
o
  LDE user information: name, email, phone 
  List of labeler DUNS to be assigned to the LDE user 
  Once accounts are created, the LDE user receives temporary login and password via system 
o
generated email. 
  HL7 SPL ONLY submitters, please refer to section 3.2.2 for additional details. 
 
3.1.1.3  GUDID Account Changes 
 
To make changes to an existing GUDID account, please contact the FDA UDI Help Desk by visiting 
www.fda.gov/udi . We recommend that you identify an individual in your organization to manage GUDID 
account changes.  
 
Account changes may include: 
  Update Regulatory Contact information 
  Add/update Coordinator information 
  Change assignment of Labeler DUNS to Coordinators 
  Add Labeler DUNS 
  Add/update third-party submitter information 
  Account changes related to mergers/acquisitions that may impact DI records  current version of 
GUDID has not implemented capability to handle all use-cases surrounding mergers/acquisitions. We 
are actively working to identify requirements for future system implementation. We request that you 
please contact us if you anticipate a merger/acquisition that may impact your DI records, so we can 
work proactively to address your situation. 
 
  3.1.2    Device Identifier (DI) Record 
 
Recall from Section 2, that a UDI = Device Identifier (DI) + Production Identifier (PI). 
  
The DI, together with associated data attributes15, constitutes a DI Record in the GUDID, and contains 
identifying information for a particular device version or model. Please note that information presented in this 
section applies to both GUDID submission options  Web Interface and HL7 SPL xml file submission. 
 
The following are key characteristics of a DI Record in GUDID: 
  GUDID will only contain the DI; the PI is never part of the GUDID.  However, the GUDID will contain 
production identifier flags, to indicate which PI attribute(s) (lot or batch number, serial number, 
expiration date, manufacturing date and donation identification number) appear on the label of the 
device, unless excepted.  
  Primary DI: Each DI record will have a Primary DI, which is the primary key for the record.  This is the 
DI of the lowest level of a medical device package containing a full UDI.  The lowest packaging level is 
also the base package.  
                                                                                                                                                                                                                        
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUD
D/UCM396841.pdf  
 
15 See GUDID Data Elements Reference Table, available on www.fda.gov/udi for a list of data attributes 
13  Contains Nonbinding Recommendations 
 
  Under 21 CFR 830.40(a), a version or model of a device may be identified using only one DI 
o
from a given FDA accredited issuing agency. The same version or model may be identified by 
UDIs from other FDA accredited issuing agencies; labelers must identify the DI from one 
issuing agency as the Primary DI in GUDID and the DIs from other issuing agencies may be 
listed as Secondary DIs (see below).  
  The DI record may also contain additional device identifiers: 
  Secondary DI: An identifier that is an alternate (secondary) lookup for a medical device that is 
o
issued from a different FDA accredited issuing agency than the primary DI.   
  Unit of Use DI: A virtual identifier assigned to an individual medical device when a UDI is not 
o
labeled on the individual device at the level of its unit of use. Its purpose is to associate the use 
of a device to/on a patient when a base package contains more than one device. The package 
configuration example in Appendix A, Figure 1, includes a Unit of Use DI. 
  Direct Marking DI: An identifier that is permanently marked directly on the medical device; can 
o
be the same as or different from the Primary DI; only applicable to devices subject to Direct 
Marking requirements under 21 CFR 801.45. 
  Package DI: A device identifier for the package configuration that contains multiple units of the 
o
base package (does not include shipping containers16). 
  Package information for a particular version or model of a device is part of the DI record.  
See section 3.1.2.1 below for more information. 
 
Note that the current implementation of GUDID does not include the ability to capture the previous 
DI as required under 21 CFR 830.310(b)(2). This may be included in a future implementation of 
GUDID.  Labelers will be provided sufficient notice and time to incorporate changes into their 
source systems. 
 
  All DIs will be checked for uniqueness in the GUDID.  Once used, a DI can never be reassigned to 
another device, even if the original device is no longer in commercial distribution. 
  When Commercial Distribution End Date <= today (i.e. today or a date in the past), the device 
o
will be considered no longer held or offered for sale by the labeler.  The device may or may not 
still be available for purchase in the marketplace. 
  The device will still be in the database and available via public search, but will be noted as Not 
o
in Commercial Distribution. 
 
Each DI record will be subject to GUDID business rules to ensure data quality. GUDID business rules for each 
data attribute are provided in the GUDID Data Elements Reference Table, available on www.fda.gov/udi. 
 Business rules include the following: 
  Required data attributes must be provided  see GUDID Data Elements Reference Table, available on 
www.fda.gov/udi  for a list of required attributes. While some fields in GUDID are not required, we 
recommend that labelers populate all fields applicable to the device, when the information is available 
in device labeling.  For example, while Device Description is not required in GUDID, if you populate 
this attribute, users will benefit from the information. 
  Validation of specified attributes.  For example, the FDA Listing Number provided must be valid. 
  Data constraints on specified attributes.  For example, Publish Date must always be >= today (i.e., today 
or a date in the future). 
                                                           
16 The UDI Final Rule defines a Shipping Container as a container used during the shipment or transportation of devices, and whose 
contents may vary from one shipment to another. 
14  Contains Nonbinding Recommendations 
 
  System rules that determine available user actions based on the status of the DI record.  For example, 
only Unpublished and Published DI records can be copied. Sections 3.1.3.1 and 3.2.1.1 provide system 
rules for each DI record state. 
 
3.1.2.1  Package Information in GUDID 
 
According to 21 CFR 801.3, a device package is a fixed quantity of a particular version or model of a device. In 
order to adequately identify a device throughout distribution and use, the various package configurations, i.e. 
each different type of package, must have a unique identifier, 21 CFR 801.20(a)(2).  Thus, if a device is sold in 
individual device packages, that are sold in boxes of thirty (30) device packages, that are sold in cartons that 
contain twelve (12) boxes of thirty (30) device packages, a different DI would be required to appear on the 
individual device package, on the box of thirty packages, and on the carton of twelve boxes of thirty device 
packages.  
 
 
Following are key points to note regarding package information in GUDID: 
 
  The Primary DI number for a DI record identifies the lowest level of medical device package containing 
a full UDI; also known as the base package.  The Primary DI, therefore, is also the base package DI. 
  The Device Count attribute provides the number of medical devices in the base package. 
  Package configurations of the base package are part of the base package DI record. 
  Package configurations inherit base package attribute values.  Therefore, Package DIs do not need their 
own DI record; instead package information may be entered in the Package DI section of the Primary DI 
record for that device.  Attributes specific to each package may be entered and include: 
  Package Device Identifier  DI for the particular package configuration (does not include 
o
shipping containers). 
  Contains DI Package DI for the lower level package configuration contained within that 
o
particular package configuration (what is the DI for the package inside this package?).  
  Quantity per Package  number of packages contained within the particular package 
o
configuration with a unique DI (how many packages are inside this package?).  
  Package Type  optional text to describe the outer packaging of the product (box, carton, etc.) 
o
and enables users to understand  higher-level packaging configurations. 
  Package Discontinue Date  indicates the date a particular package configuration is discontinued 
o
by the labeler. 
  Package Status indicates whether the package configuration is in commercial distribution as 
o
defined under 21 CFR 807.3(b); auto-populated by the system based on Package Discontinue 
Date: 
  If Package Discontinue Date > today (i.e., a date in the future) or null, then Package 
Status = In Commercial Distribution  
  If Package Discontinue Date =< today (i.e., today or a date in the past), then Package 
Status = Not In Commercial Distribution 
 
Figure 2 provides a package configuration example for GUDID where the DI is on the individual device with 
one package level.  
  Oral/enteral syringe, each with Primary DI 00884838035683 and Device Count = 1. 
  Box of 100 syringes, with Package DI 30884838035684 (contains 100 units of Primary DI 
00884838035683). 
15  Contains Nonbinding Recommendations 
 
  Package Discontinue Date is blank (null); therefore Package Status is set to In Commercial Distribution. 
 
Package 30884838035684 inherits all attribute values of base package 00884838035683, except for the 
attributes specific to 30884838035684, as shown in the table below. 
 
   
 
Base Package 
Primary Device Identifier  Device Count 
00884838035683  1 
Package Information 
Package DI  Quantity  Contains DI  Package  Package  Package Status 
per  Package  Type  Discontinue 
Package  Date 
30884838035684  100  00884838035683  Box    In Commercial Distribution 
Figure 2: Package Configuration Example17 
 
Additional examples of package configurations, along with attribute values pertinent to packages, are provided 
in Appendix A. 
 
3.1.2.2   Global Medical Device Nomenclature (GMDN) 
 
Each DI record in GUDID requires entry of at least one GMDN Preferred Term (PT) codes. The GUDID 
business rules allow more than one GMDN term to be assigned per DI record, but this allowance was 
developed for the rare occurrence where more than one term is needed to accurately describe the device.  It is 
expected that most records would assign one, and only one, GMDN term. 
 
                                                           
17 Device Identifiers used in the example are fictitious. Please refer to UDI Formats by FDA Accredited Issuing Agency in Appendix 
C for correct format of the DI numbers by FDA Accredited Issuing Agencies 
16  Contains Nonbinding Recommendations 
 
GMDN is a system of internationally agreed upon descriptors used to represent common device types for the 
purposes of grouping or categorization. GMDN terms, managed by the GMDN Agency, have been developed 
over the past 20 years as a vocabulary that represents the whole medical device arena, including such specialties 
as dental products, laboratory equipment, in vitro diagnostics, and biologic devices with cellular or tissue 
origins. Each GMDN Preferred Term (PT) has 3 components:  Preferred Term Code (5-digit number), 
Preferred Term Name, and Preferred Term Definition.  GMDN is maintained and updated to represent the 
evolving medical device field; meaning PT names and Definitions may be edited, new terms may be developed 
and out-dated terms may be made obsolete. 
 
The GUDID represents the first implementation of the Global Medical Device Nomenclature (GMDN) within 
FDA.  To obtain access to the GMDN vocabulary and to select GMDN terms for submission to the GUDID, 
companies should first become a member of the GMDN Agency. Visit http://www.gmdnagency.com  for 
details. While GMDN Membership is not required (see GUDID Search Module below), the GMDN Agency 
offers benefits and services with its Codes that arent available through the free-access GUDID search module. 
 
Prior to submission of DI records to the GUDID, ensure the following: 
  Identify and obtain appropriate GMDN terms for devices requiring GUDID submission.  
  NOTE: if a device requires the development of a new device category, or a new Preferred Term, this 
requires time, so please plan accordingly. 
  When selecting a GMDN term, be advised that GMDN Definitions may contain language with a 
o
specific regulatory definition or implication to FDA.  Assignment of a GMDN term with such 
language in the name or definition to your DI record does not imply agreement by FDA to a 
particular regulatory interpretation for your device.   
  If your company has GMDN terms that are currently in use, use the GMDN Agency as a resource to 
evaluate the following:  
  Term fitness  determine if this GMDN term or device category best represents the device   
o
  Term Status -- determine if terms are active or have been made obsolete  
o
  If your companys Codes have been designated as obsolete, identify replacement terms by 
o
searching the GMDN vocabulary or contacting the GMDN Agency for assistance. 
  NOTE:  GMDN terms accepted by other regulatory authorities may not be acceptable terms for 
o
GUDID DI record submission. The GUDID implementation of GMDN recognizes only active 
GMDN terms.  
  Submit only active GMDN terms to the GUDID. 
 
During submission of DI records: 
  For DI record entry via the web user interface, the GMDN PT Code should be used to assign the 
GMDN term to the record; the Name and Definitions fields would be auto-populated.  (For submission 
of GMDN terms in HL7 SPL xml files, see GUDID HL7 SPL Implementation Specification files, 
available at www.fda.gov/udi ) 
 
Maintaining GMDN Codes in DI Records: 
  It is the responsibility of labelers to make sure their DI record information is accurate and up-to-date.  If 
you maintain a membership with GMDN, the Agency notifies you when your terms have been modified 
or made obsolete. If not, it would be your responsibility to update your GMDN terms periodically or 
when required to by validation rules (see next bullet). 
  If a GMDN term becomes obsolete, the labeler/LDE should update the GMDN term in order to pass 
validation when updating any other DI record attribute.  An obsolete GMDN term doesnt require an 
17  Contains Nonbinding Recommendations 
 
update, in and of itself, but when editing other attributes the DI record would not pass validation/review 
without an active GMDN term. 
  Once a DI record has been published in the GUDID with an active GMDN term, that assignment 
remains until deliberately changed by the labeler/LDE.  There is no automatic update of GMDN terms 
within the GUDID. 
  If GMDN information changes, the updated information must be submitted within 10 business days of 
the change per 21 CFR 830.330(b). 
 
GUDID GMDN Search Module 
 
As stipulated in the Final UDI Rule [78 FR 58786], FDA has developed a GUDID search module, Find FDA 
PT Codes that enables users to select a GMDN term to be used in their GUDID submission until a GMDN 
Code can be obtained from the GMDN Agency.   The FDA Preferred Term (PT) Codes are a 4-letter code 
assigned to each GMDN term, in place of the GMDN Code.  The FDA PT Code is accepted into the GMDN 
Code attribute field in the DI Record and the GMDN Name and Definitions are auto-populated, as from 
GMDN Codes.  The data entry requirement is met by entering a GMDN Code (5-digit) or FDA PT Code (4-
letter); there is no need to enter both.  Please do not attempt to enter a GMDN Code and an FDA PT Code for 
the same GMDN term.  Since the FDA PT Codes only apply to GUDID DI Record entry and cannot be used in 
place of GMDN Codes for any other system, we encourage GUDID submitters to obtain the GMDN code and 
replace the FDA PT code as soon as possible.  FDA PT Codes are also accepted in HL7 SPL xml document 
submission, but the same limitations apply.  (For more details on GMDN entry in HL7 SPL xml files, see 
GUDID Draft HL7 SPL Implementation Specification, v1.1 at www.fda.gov/udi ) 
 
The Find FDA PT Code module can be found on the GUDID homepage after logging-in with a username and 
password.  The Find module is separate from the DI record data entry module.  There is no access to the Find 
FDA PT Codes module from within a DI record.  An LDE User should first search and select a GMDN PT 
Name (and associated FDA PT Code) for a specific device; then enter a DI record and use the FDA PT Code to 
assign the GMDN Name and Definitions to the DI record.   
 
Labelers in need of assistance with term selection or new term development are encouraged to contact the 
GMDN Agency, www.gmdnagency.com.   
  
NOTE:  Representation of GMDN in Appendix D, Figure D1, a Fictitious Medical Device Label is for 
illustration purposes ONLY.  GMDN PT Name and Definition are NOT expected to appear on the label of a 
device.   
3.1.3    DI Record Life-Cycle  
 
The GUDID DI Record Life-Cycle comprises the various states of a DI record and the associated business rules 
and functionality available to a user. Please note that the DI record life-cycle applies to both GUDID 
submission options  Web Interface and HL7 SPL xml file submission; where there are differences due to the 
type of submission, they have been noted.  
 
3.1.3.1   DI Record States 
 
A DI record is in one of three DI record states at any given time.  The DI record state determines the applicable 
business rules and the GUDID functionality available to users.  
 
18  Contains Nonbinding Recommendations 
 
A new DI record may be saved in one of the following three DI record states: Draft DI record, Unpublished DI 
record, or Published DI record. Only DI records in a published state will be considered to have met the GUDID 
submission requirements under 21 CFR 830 Subpart E. 
 
Draft DI Record: enables you to prepopulate and save a DI record with the available information via the 
GUDID Web Interface. Additionally, users may also create Draft DI records to get familiar with creating and 
saving DI records in GUDID; however, please do not Submit records for publishing when created solely for the 
purpose of familiarizing yourself with the system. Merely creating and saving Draft DI records does not fulfill 
your GUDID submission requirements under 21 CFR 830, subpart E. Please note that the Draft DI record state 
is only applicable to the GUDID Web Interface option.  HL7 SPL submissions cannot be submitted as Draft DI 
records.  
 
A Draft DI record: 
  does not have to pass any business rules prior to being saved as a Draft DI record. 
  can be edited an unlimited number of times via the GUDID Web Interface. 
  can be saved in the Draft DI record state for 180 calendar days; the record will be purged, i.e., 
permanently removed from the GUDID, after 180 calendar days of inactivity. 
  Please note that the 180-day cycle resets and starts over each time the Draft DI record is edited 
o
and re-saved as a draft.  
  can only be viewed/edited by the LDE user who created the record. 
  is not available for public search and retrieval. 
 
A Draft DI record must pass Review, i.e., pass business rules before it can be Submitted to GUDID. Upon 
submission, the record then can be in Unpublished or Published state based on the Publish Date: 
  Unpublished state means Publish Date > today (i.e., a date in the future). 
  Published state means Publish Date =< today (i.e., today or a date in the past). 
 
Unpublished DI Record: enables users to complete a DI record and Submit it to GUDID prior to the required 
date. Saving unpublished DI records alone does not fulfill your GUDID submission requirements under 21 
CFR 830, subpart E. 
 
An Unpublished DI record: 
  has passed all business rules, i.e., has passed Review. 
  has not reached the Publish Date (Publish Date > today (i.e., a date in the future)). 
  can be edited unlimited number of times; however, each time the record is edited, the record must pass 
business rules, i.e., Review again. 
  can be copied to create new DI records, enabling reduction of data entry time; all attributes except for 
the Primary DI number and package information are copied. 
  can be viewed by the FDA and LDE users assigned to the Labeler DUNS associated to the given DI 
record. FDA may review your Unpublished DI records for data quality assessment and contact you with 
questions. 
  is not available for public search and retrieval. 
  will be checked by an automated GUDID nightly process, and when Publish Date = today, the record 
will move to the Published DI record state. 
 
19  Contains Nonbinding Recommendations 
 
Published DI Record: a DI record that is available for search and retrieval by the public. We will consider you 
to have complied with the requirements of 21 CFR 830.330 on the date that the DI record is saved in GUDID 
in the published state. 
 
A Published DI record: 
  has passed all business rules, i.e., has passed Review. 
  has Publish Date =<today (i.e., today or a date in the past). Please note that a DI record entered with 
Publish Date = today, will be available for public search immediately. 
  can be copied to create new DI records, enabling reduction of data entry time; all attributes except for 
the Primary DI number and package information are copied. 
  is available for public search and retrieval. 
  is subject to editing limitations as determined by the Grace Period. The Grace Period is 7 calendar days 
and starts the day after the DI record is published. 
 
 
Publish Date  Grace Period Start Date  Grace Period End Date 
Monday, July 15, 2013  Tuesday, July 16, 2013  Monday, July 22, 2013, 11:59 PM 
 
  Editing within-the-Grace-Period 
o
  all attributes, except Publish Date can be edited. 
  Editing after-the-Grace-Period will be limited 
o
  New DI trigger attributes cannot be edited; these are core attributes which, when changed, 
no longer represent the same device and require a new DI. 
  certain attributes would have limited editing capability; a complete list of edit rules are 
available in the Data Elements Reference Table, available on www.fda.gov/udi .  For 
example: 
  FDA Premarket Submission Number: 
-  can Add Premarket Submission Numbers after the grace period 
-  cannot Edit or Delete existing values after the grace period 
  in the rare situation where New DI trigger attributes or attributes with limited editing need to 
be edited after-the-grace-period18, you may contact the FDA UDI Help Desk and request 
assistance.  
  FDA Staff will review your request and move your record to the Unpublished DI record 
state 
  You may make the necessary edits and submit the DI record again to be published. 
 
Please note that Published DI records for devices removed from commercial distribution will remain in the 
published state and will be available for public search and retrieval. It is the responsibility of the labeler to 
update the DI records for discontinued devices. The Commercial Distribution Status will be auto-populated by 
the system based on Commercial Distribution End Date as shown below. 
  When Commercial Distribution End Date> today (i.e., a date in the future) or null, Commercial 
Distribution Status = In Commercial Distribution 
  When Commercial Distribution End Date =<today (i.e., today or a date in the past) , Commercial 
Distribution Status = Not In Commercial Distribution 
                                                           
18 Edits to New DI trigger attributes and attributes with limited editing after-the-grace-period is expected to be an extremely rare 
occurrence. Labelers should ensure their DI record data is accurate before the record moves to the published state. 
20  Contains Nonbinding Recommendations 
 
 
The table below provides a summary of the three DI record states: 
 
DI Record  Description  System Save duration  Possible Actions  Available via Public 
State  on the DI Record  Search? 
Draft DI  Saved DI record that has  Purged after 180  --Unlimited editing  --No  
record  not passed business  calendar days of  --Resave as Draft  --only available to the LDE 
rules  inactivity; if edited and  --Delete Draft  user who created the 
Please note that HL SPL  resaved as draft, the  --Must pass business  record 
Submissions cannot be  180-calendar day cycle  rules and be 
submitted as Draft DI  resets and starts over   Submitted to move 
records. This state is  to other DI record 
only applicable to the  states 
GUDID Web Interface 
option. 
Unpublished  DI record that has  Saved indefinitely  -- Copy   --No 
DI record  passed GUDID business  --Unlimited editing  -- available for editing by 
rules, been Submitted  --System publishes  LDE users assigned to the 
to GUDID AND  DI record when  particular Labeler DUNS 
 Publish Date > today  Publish Date = today  number 
(i.e., in the future)  --can be viewed by FDA 
Published DI  DI record that has  Saved indefinitely  --Copy  --Yes 
record  passed GUDID business  --Limited editing  -- available for editing by 
rules, been Submitted  during and after  LDE users assigned to the 
to GUDID AND  Grace Period based  particular Labeler DUNS 
 Publish Date <= today  on business rules  number 
(i.e., today or in the  --can be viewed by 
past)  Coordinators, LDE users, 
--Cannot move to other  FDA, Public Users 
DI states without FDA 
staff intervention 
Table 1: Summary of DI Record States  
3.2  GUDID Modules 
 
Now that the key GUDID concepts are familiar, this section provides a description of the GUDID Modules.  
 
The GUDID provides two options for submission of device identification information:  
1)  Submission of one DI record at a time via the secure GUDID Web Interface. 
2)  Submission of one DI record per XML file via the HL7 SPL submission option. 
 
Both submission options require a GUDID account. Please note that the GUDID account is not by submission 
type, i.e., a labeler does not need to have a separate GUDID account for each submission option. The GUDID 
account identifies the labeler in GUDID and enables submission of device information via both options.  
 
The overall concepts presented in this guidance document apply to both submission options. Where there are 
differences, they have been noted. 
 
21  Contains Nonbinding Recommendations 
 
GUDID provides two information retrieval options for published DI information: 
1)  Search and retrieval of device information via the web interface 
2)  Download and web service capabilities are planned for the future 
 
GUDID accounts are NOT required for search and retrieval of published information. 
 
During the initial implementation, GUDID Public Search will be temporarily disabled until a meaningful 
dataset of DI records have been created. 
 
Figure 3 provides a pictorial representation of the GUDID modules described above. 
   
Figure 3: GUDID Overview 
 
  3.2.1    GUDID Web Interface 
 
The GUDID Web Interface module enables creation of GUDID accounts, submission of DI records, and search 
and retrieval of device information.  For details related to account creation, see section 3.1.1. This section 
focuses on submission of device information; search and retrieval details are presented in Section 3.2.3. 
 
22  Contains Nonbinding Recommendations 
 
 
 
 
3.2.1.1   GUDID Device Identifier Module  
 
The Device Identifier (DI) module enables creation and management of DI records by LDE users.  As indicated 
in Section 3.1.1.2, when coordinators create LDE users, LDE users will receive a temporary login and password 
via a system generated email.  LDE users may then login and use the GUDID. 
 
The DI module enables LDE users to: 
  Create DI records. 
  Save, edit, and manage Draft DI records. 
  Review and validate DI records against system business rules. 
  Copy Unpublished and Published DI records.  
  Edit and manage Unpublished and Published DI records. 
  Search and retrieve ALL attributes of DI records for their assigned Labeler DUNS numbers. Note that 
this is different from public search users who can only view attributes indicated public in the Data 
Elements Reference Table, available on www.fda.gov/udi . 
 
The next few sections detail the DI record life-cycle functions in GUDID19. These include: 
  Creating a New DI Record 
  Editing a Draft DI Record 
  Editing Unpublished or Published DI Records 
  Copying DI Records 
 
  3.2.1.1.1  Creation of a New DI Record 
 
When created using the GUDID Web Interface, the DI record life-cycle begins with the creation of a new DI 
record, see Figure 4.  Draft DI records cannot be submitted via the HL7 SPL submission option. Once created, 
a new DI record may be saved as a Draft DI record and Reviewed against the business rules.  Based on the 
Publish Date, the record would then be promoted to the Unpublished or Published DI record state.  
 
Figure 4 provides a pictorial representation of the new DI record creation process which is explained below. 
 
                                                           
19 For detailed information on the accessing and creating DI records in GUDID, please refer to the Global Unique Device 
Identification Database (GUDID) User Manual, available at -- 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUD
ID/UCM396841.pdf 
23  Contains Nonbinding Recommendations 
 
Figure 4: Creating a New DI Record 
 
After creating a new DI record, the LDE user may choose to: 
  Save the record as Draft DI record. 
  Cancel creation of a new DI record. 
  Review DI record to run GUDID business rules 
  If the record FAILS business rules, the user can: 
o
  Save as Draft DI record so errors can be fixed at a later time. 
  Cancel creation of new DI record. 
  If the record PASSES business rules, the user can: 
o
  Resave as Draft DI record. 
  Edit record further; once edited, the record must pass business rules again; it can be 
saved as Draft DI record, or edits can be Cancelled. 
  Cancel creation of new DI record. 
  Submit the record to GUDID; the DI record state will be set by the system based on 
Publish Date. 
  Unpublished state means Publish Date > today (i.e, a date in the future). 
  Published state means Publish Date <= today (i.e., today or a date in the past). 
 
Note that Submitting a DI record to GUDID does not fulfill your GUDID submission requirements. We will 
consider you to have complied with the requirements of 21 CFR 830.330 on the date the DI record is saved in 
the published state.   
 
  3.2.1.1.2  Editing a Draft DI Record 
 
As noted above, a new DI record created via the GUDID Web Interface can be saved as Draft DI record20, 
which can move to other DI record states after it passes business rules. Draft DI records can be edited and 
resaved as Draft DI records.  
 
                                                           
20 Draft DI records cannot be submitted via the HL7 SPL submission option. 
24  Contains Nonbinding Recommendations 
 
Figure 5 provides a pictorial representation of editing a Draft DI record, which is explained below. 
Figure 5: Editing a Draft DI Record 
 
The LDE user can edit the Draft DI record and: 
  Save as Draft again.  Recall that Draft DI records can be edited and resaved as drafts an unlimited 
number of times.  
  A Draft DI record is purged from the system,  i.e., permanently removed from GUDID, after 180 
o
days of inactivity. 
  Each time a Draft DI record is edited, the 180 calendar day clock is reset as shown in the table 
o
below. 
  Delete the Draft DI record. 
  Cancel the edits. 
  Review the Draft DI record to run GUDID business rules. See section 3.2.1.1.1, Creation of New DI 
Record, for details of the Review process. 
25  Contains Nonbinding Recommendations 
 
 
Table 2 below provides an example of how the purge date is reset.  
 
Primary DI  User Action  User Action  Draft DI  Purge Date  Comments 
Number  Date  Record Edit 
Date 
100  December 7,  Enter and  December 7,  June 5, 2013  Draft DI 
2012  save a DI  2012  records are 
record as a  saved in the 
draft via the  system for 180 
GUDID Web  calendar days 
Interface   after which the 
record is 
purged 
100  December 17,  Edit record,  December 17,   June 15, 2013  Purge date is 
2012  resave as  2012  reset each time 
draft via the  the record is 
GUDID Web  edited and 
Interface  saved 
Table 2: Draft DI Purge Date Examples 
 
  3.2.1.1.3  Editing Published or Unpublished DI Records 
 
A DI record that has passed all business rules, i.e., is Reviewed and Submitted, automatically moves to either 
the Published or Unpublished DI record state based on the Publish Date, as explained earlier.  
 
Published and Unpublished DI records can be edited as follows:  
  Unpublished DI records can be edited an unlimited number of times and all attributes may be edited; 
however, once edited, the record must go through Review and pass business rules again. 
  The extent of editing on a Published DI record is determined by the Grace Period, which starts the day 
after the DI record is published and ends after 7 calendar days.  As explained earlier in the document:  
  within- the-grace period, all attributes, except Publish Date can be edited. 
  after-the-grace-period, editing will be limited.  
  New DI trigger attributes cannot be edited; these are attributes, which when changed, no 
longer represent the same device and would require a new DI. 
  Certain attributes will have limited editing capability.  
  See the GUDID Data Elements Reference Table, available on www.fda.gov/udi , for edit 
rules for all attributes. 
 
Table 3 below illustrates the Grace Period concept via an example. 
 
Primary  User/System  User/System  Publish Date  Grace  Grace Period  Comments 
DI  Action Date  Action  Period Start  End Date 
Number  Date 
100  July 19, 2013  Create a new DI  July 29, 2013  N/A  N/A  Unpublished record, 
record, pass  grace period does 
business rules;  not begin until the 
save.  record is published 
26  Contains Nonbinding Recommendations 
 
Primary  User/System  User/System  Publish Date  Grace  Grace Period  Comments 
DI  Action Date  Action  Period Start  End Date 
Number  Date 
100  July 23, 2013  Edit record,  July 25, 2013  N/A  N/A  Unpublished record, 
change publish  grace period does 
date  not begin until the 
record is published 
100  July 24, 2013  GUDID nightly  July 25, 2013  July 26,  August 1,   
system process  2013  2013, 
publishes the  11:59PM 
record  
100  July 27, 2013  Edit New DI  July 25, 2013  July 26,  August 1,  Once published, 
trigger attribute  2013  2013,  grace period does 
within grace  11:59PM  not reset 
period, check 
that device is 
combination 
product 
100  August 2,  Attempts to edit  July 25, 2013  July 26,  August 1,  New DI trigger 
2013  a New DI trigger  2013  2013,  attributes CANNOT 
attribute, Version  11:59PM  be edited after 
or Model  grace period ends 
Number, but can 
not 
Table 3: Grace Period Example 
 
In addition to editing Draft DI records as explained in Section 3.2.1.1.2, the LDE user can edit Unpublished or 
Published DI records and: 
  Review the edited DI record to run GUDID business rules. See Section 3.2.1.1.1 above on Creation of a 
New DI Record for details of the Review process. 
  Cancel the edits. 
 
Figure 6 provides a pictorial representation of editing an Unpublished or a Published DI record. 
27  Contains Nonbinding Recommendations 
 
Figure 6: Editing an Unpublished or a Published DI Record 
 
There is a key difference between editing a Draft DI record and editing an Unpublished or a Published DI 
record:  
  after editing a Draft DI record, it can be resaved as a Draft DI record.  
  after editing an Unpublished or a Published DI record, the record CANNOT be saved as a Draft DI 
record; the record has to pass business rules.  The record must be Reviewed and Submitted or the edits 
will be cancelled. 
 
All edits to Unpublished and Published DI records are logged in GUDID. LDE users may view the following 
information about the history of a DI record via the GUDID Web Interface  Edit Date, Edit Time and Name of 
the user who edited the DI record; for submissions edited via the HL7 SPL submission option, user is noted as 
SPL User. Details of which attributes were edited are presently not exposed and therefore not viewable by 
users. DI record history information is not exposed to public users of GUDID when a record is retrieved via 
GUDID Public Search. 
 
GUDID offers two DI record submission options, the GUDID Web Interface and the HL7 SPL submission 
option. Entering a record via one option and editing via another option allows for the possibility of 
inconsistencies between the labelers source data and GUDID data. Therefore, for all edits to a DI record, we 
recommend you use the same submission option you used to initially create and submit the DI record to 
GUDID. The labeler is responsible for developing and maintaining SOPs for data quality and data integrity 
with respect to GUDID submissions. 
 
  3.2.1.1.4  Copying DI Records 
 
Unpublished and Published DI records can be copied while using the GUDID Web Interface, however Draft DI 
records cannot.  
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  The GUDID Web Interface DI record Copy function  enables the user to copy all attributes of a DI 
record to a new DI record, except for the Primary DI number21 and package information.  This enables 
the user to reduce data entry time.  
  A copied record begins as a Draft DI record and must pass business rules to be promoted to other DI 
record states. 
 
Figure 7 provides a pictorial representation of the Copy functionality in GUDID as explained below. 
 
Figure 7: Copying DI Records 
 
The LDE user can Copy Unpublished and Published DI records and: 
  Save as a Draft DI record.  Recall that the copied DI record begins as a Draft DI record and follows the 
DI record life-cycle to move to other DI record states. 
  Cancel the copy action; the new DI record would not be saved in GUDID. 
  Review the Copied DI record against GUDID business rules.  See Section 3.2.1.1.1 above on Creation 
of a New DI Record for details of the Review process. 
 
3.2.2   HL7 SPL Submission  
 
The HL7 SPL Submission option enables companies to electronically submit device information one DI record 
at a time as an HL7 SPL xml file via the FDA ESG.  For detailed technical specifications on HL7 SPL 
submission option, please refer to the GUDID HL7 SPL Implementation Files, available at 
http://www.fda.gov/udi .  
 
Companies that choose the HL7 SPL submission option would need to do the following: 
  Establish a GUDID account.  See Section 3.1.1 for details. 
                                                           
21 Primary DI Number is the Device Identifier on the base package of a medical device. 
29  Contains Nonbinding Recommendations 
 
  Coordinator and Labeler Data Entry user roles are optional for HL7 SPL submissions since 
o
submissions are sent as XML files. However, if labelers choose to have Coordinator and LDE 
users, they may do so. 
  Use the FDA ESG to submit HL7 SPL files. 
  Complete ESG account establishment and testing process. Visit www.fda.gov/esg for more 
o
information. 
  Once GUDID and ESG accounts are established, companies would be required to complete GUDID 
testing prior to production submissions. Detailed information on testing requirements/process is 
available as part of the GUDID HL7 SPL Implementation Files on http://www.fda.gov/udi  
  Companies may choose to use third-party submitters to submit device information on their behalf.  
Please review Section 3.1.1 for more information on using a third-party to submit device information to 
GUDID. 
  We are enabling third-parties to test their GUDID HL7 SPL submission solution by providing 
o
them with test GUDID accounts. Labelers using third-parties who may have completed testing 
must still complete the test scenarios listed as part of the GUDID HL7 SPL Implementation 
Files prior to moving to production GUDID HL7 SPL submissions. 
 
3.2.3    Search/Retrieval of Device Information 
 
The GUDID Search and Retrieval module would enable public users, i.e., consumers, health-care providers, 
hospital systems, to access published GUDID data.  Published data would include all DI record attributes with 
a few exceptions such as:  Labeler DUNS Number, Company Physical Address, GMDN Preferred Term Code, 
FDA Listing Number, etc. Please see the GUDID Data Elements Reference Table, available on 
www.fda.gov/udi for a list of attributes that are not released to the public. 
 
During the initial implementation, GUDID Public Search will be temporarily disabled until a meaningful 
dataset of DI records have been created. 
 
As indicated earlier, there would be two Search and Retrieval options available in GUDID: 
  Search and retrieval of device information via the Web Interface 
  System to system search and retrieval  
 
Please note that GUDID accounts are not necessary for search or retrieval of published information.   
 
3.2.3.1  GUDID Web Interface Search and Retrieval 
 
The GUDID Web Interface search and retrieval module would provide the ability to: 
  Search published GUDID data  
  View results 
  Export results as xml files 
 
Two search options are available via the GUDID Web Interface: 
  Quick Search  allows search on the following attributes: Device Identifier, Company Name, Brand 
Name, GMDN Preferred Term Name and Model Number.  
  Advanced Search  allows search on additional GUDID attributes. 
 
30  Contains Nonbinding Recommendations 
 
3.2.3.2  GUDID System to System Search and Retrieval  
 
We plan to make available all published GUDID data as download files. Additionally, we also plan to make 
available basic web service functionality. Additional information on both these capabilities will be provided on 
the UDI webpage when available. 
4   GUDID Submissions and 21 CFR 11 Requirements  
 
There are two requirements necessary for Part 11 applicability: 
1)  Records that are required to be maintained (under predicate rules) or submitted to FDA 
2)  Records that are kept in electronic format, as opposed to paper 
 
Labelers should become familiar with all the requirements of 21 CFR 11 and the Guidance document (Part 11 
Electronic Records; Electronic Signatures  Scope and Application, which can be found at: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf) which further defines a 
narrowed scope and identifies the requirements  for which compliance is most important  while Part 11 is being 
re-examined.  When reading the Guidance document, predicate rule should be interpreted as 78 FR 58786 or 
the UDI Rule.  
 
All submitters  must retain records in accordance with 21 CFR 830.360.  If those records are kept 
electronically, part 11 applies.  However, a record that is not itself submitted, but is used in generating a 
submission, is not a part 11 record.  That is, a record developed to collect all the data elements required to be 
entered into a device record via the GUDID web user interface, is not subject to part 11 requirements. 
 
SPL submitters  must retain records in accordance with 21 CFR 830.360 and all records submitted to FDA.  
The HL7 SPL solution must be compliant with the requirements of part 11. The GUDID SPL submission 
doesnt require a signature; therefore, part 11 requirements specific to electronic signatures (21 CFR 11 
Subpart C), do not apply. However, please dont confuse an electronic signature with a digital certificate.  A 
digital certificate serves to authenticate the sender and is required for all submissions to the FDA ESG, 
including GUDID. 
 
Once an SPL submission is successfully delivered to the GUDID, labelers should be able to view and edit data 
elements via the web interface. This allows for the possibility of inconsistencies between the labelers source 
data submitted via SPL and GUDID data. Labelers should develop and adhere to SOPs for data governance to 
maintain the quality of their device data.  
 
Third-party submitters/Solutions Providers  are not responsible to the FDA to meet regulatory requirements 
for UDI or part 11.  It is the legal responsibility of the labeler (or data owner) to meet the records requirements 
for 21 CFR 830.360 and the requirements of 21 CFR 11.  The contractual language between labeler and third-
party submitter is not the purview of the FDA. 
 
5   Conclusion 
 
This document provides GUDID information based on the current implemented system version.  Enhancements 
and upgrades to GUDID are anticipated and the FDA intends to periodically update this document to reflect 
system changes. 
31  Contains Nonbinding Recommendations 
 
22
Appendix A  GUDID Package Information Examples  
 
The examples below illustrate how package information is entered into the GUDID along with attribute values 
pertinent to packages. 
EXAMPLE 1: UNIT OF USE DI + ONE PACKAGE LEVEL 
The figure below provides a package configuration example for GUDID where the medical device has Unit of 
Use DI Number and one package level. 
  Box of 100 single use blood collection tubes with the Primary DI 20001 and Device Count = 100. 
  Note that the tubes themselves do not have the DI on them as they fall under the general exception 
o
for individual single use device under 801.30(a)(3). Each tube however, gets a virtual Unit of Use DI 
assigned, and in this case, 10001. 
  Case of 8 boxes (800 total), with Package DI 30001 (contains 8 of Primary DI 20001), Quantity per 
Package = 8. 
  Package Discontinue Date is blank, therefore system auto-populates Package Status to In Commercial 
Distribution. 
Package 30001 inherits all attribute values of base package 20001, except for the attributes specific to 30001 
such as Quantity per Package, as shown in the table below. 
   
Base Package 
Primary Device Identifier  Device Count  Unit of Use DI 
20001  100  10001 
Package DI 
Package DI  Quantity  Contains DI Package  Package Type  Package  Package Status 
per Package  Discontinue Date 
30001  8  20001  Case    In Commercial Distribution 
                                                           
22 Device Identifiers used in all the examples are fictitious. Please refer to UDI Formats by FDA Accredited Issuing Agency (see 
Appendix C, available on www.fda.gov/udi ) for correct format of the DI numbers by FDA Accredited Issuing Agencies. 
 
32  Contains Nonbinding Recommendations 
 
Figure 1: GUDID Package Configuration Example 1 
33  Contains Nonbinding Recommendations 
 
EXAMPLE 2: DI ON INDIVIDUAL DEVICE + MULTIPLE PACKAGE LEVELS 
The figure below provides a package configuration example for GUDID where the DI is on the individual device 
with two package levels. 
  Catheter, 12 Fr, each with Primary DI 1001 and Device Count = 1. 
  Box of 30 catheters with Package DI 2001 (contains 30 of Primary DI 1001). 
  Case of 12 boxes (540 catheters), with Package DI 3001 (contains 12 of Package DI 2001). 
  Box of 50 catheters with Package DI 2002 (contains 50 of Primary DI 1001). 
  Package Discontinue Date is blank, therefore system auto-populates Package Status to In Commercial 
Distribution. 
Package 2001, 3001 and 2002 inherit all attribute values of base package 1001, except for the attributes specific to 
each package, as shown in the table below. 
 
Base Package 
Primary Device Identifier  Device Count 
1001  1 
Package DI 
Package DI  Quantity  Contains DI  Package  Package  Package Status 
per  Package  Type  Discontinue 
Package  Date 
2001  30  1001  Box    In Commercial Distribution 
3001  12  2001  Case    In Commercial Distribution 
2002  50  1001  Box    In Commercial Distribution 
34  Contains Nonbinding Recommendations 
 
Figure 2: Package Configuration Example 2 
35  Contains Nonbinding Recommendations 
 
 
Appendix B  GUDID Data Elements Reference Table 
 
For a complete list of GUDID attributes, please refer to the GUDID Data Elements Reference Table available at 
www.fda.gov/udi  
36  Contains Nonbinding Recommendations 
 
 
Appendix C  UDI Formats by FDA Accredited Issuing Agency 
 
For information on UDI Formats by FDA Accredited Issuing Agency, please visit www.fda.gov/udi  
37  Contains Nonbinding Recommendations 
 
 
Appendix D  GUDID Attributes Mapped to a 
Fictitious Medical Device Label 
 
Many GUDID data attributes appear on the medical device label.  When a GUDID attribute 
appears on the medical device package/label, the values submitted to the GUDID should match 
the value on the label. Figure D1 shows a fictitious medical device label and identifies the 
GUDID data attributes that appear on the label. 
 
 
Figure D1: GUDID Attributes Mapped to a Fictitious Medical Device Label 
 
NOTE:  Representation of GMDN above is for illustration purposes ONLY.  GMDN PT Name and Definition are 
NOT expected to appear on the label of a device.   
38  Contains Nonbinding Recommendations 
 
 
Abbreviations & Acronyms 
 
Term  Description 
DI  Device Identifier 
D&B  Dun & Bradstreet 
DUNS  Data Universal Numbering System 
ESG  FDA Electronic Submissions Gateway 
GMDN  Global Medical Device Nomenclature 
GUDID  Global Unique Device Identification Database 
HCT/P  Human Cell, Tissue or Cellular or Tissue-Based Product 
FDA  Food and Drug Administration 
FDAAA  FDA Amendments Act 
FDASIA  FDA Safety and Innovation Act 
HL7  Health Level 7 
PI  Production Identifier 
GMDN PT  GMDN Preferred Term 
SPL  Structured Product Labeling 
UDI  Unique Device Identifier  
 
39  Contains Nonbinding Recommendations 
 
 
Glossary 
Term  Description 
Base Package  The lowest level of a medical device package containing a full 
UDI.  The DI on the base package is the Primary DI. 
Coordinator  Individual(s) responsible for management of the GUDID 
account, for designated Labelers. 
Data Universal  A unique 9-digit identification number assigned and managed by 
Numbering System  Dun & Bradstreet to business entities.  
(DUNS) 
Device Identifier (DI)  A mandatory, fixed portion of a UDI that identifies the labeler 
and the specific version or model of a device.  
Device Identifier  The DI, together with associated data attributes constitutes a DI 
Record (DI Record)  record for a particular device version or model. 
DI Record Life-Cycle  Comprises of the various states of a DI record and the associated 
business rules and functionality available to a user. 
DI Record States  A DI Record is in one of three DI Record States at any given 
time: Draft DI Record, Unpublished DI Record, or Published DI 
Record. 
Direct Marking DI  An identifier that is marked directly on the device; can be the 
same as or different from the Primary DI; only applicable to 
devices subject to Direct Marking requirements under 21 CFR 
801.45. 
Device Package  A package that contains a fixed quantity of a particular version or 
model of a device. 
Draft DI Record  Saved DI record that has not passed business rules. 
Electronic Submissions  An FDA-wide solution for accepting secure electronic regulatory 
Gateway (ESG)  submissions.  
FDA Preferred Term  The FDA Preferred Term (PT) Codes are a 4-letter code assigned 
to each GMDN term, in place of the GMDN Code. FDA PT 
Codes only apply to GUDID DI Record entry ONLY and cannot 
be used in place of GMDN Codes for any other system. 
Global Medical Device  A system of internationally agreed descriptors used to identify 
Nomenclature (GMDN)  medical device products and is managed by the GMDN Agency. 
Grace Period  Seven calendar days and starts the day after the DI record is 
published; determines the extent of editing possible on a DI 
record. 
GUDID  Global Unique Device Identification Database, the repository of 
device identification information for devices specified under the 
FDA UDI Final Rule. 
GUDID Account  A GUDID account enables companies to access and submit 
information to the GUDID.  
40  Contains Nonbinding Recommendations 
 
Term  Description 
GUDID Web Interface  An online interface that enables secure account creation, secure 
submission of DI records, and search and retrieval of device 
information. 
Health Level 7 (HL7)  A standards development organization, whose mission is to 
provide messaging standards for interoperability, exchange, 
management, and integration of data that supports clinical patient 
care and the management, delivery, and evaluation of healthcare 
services. 
Issuing Agency  Organization accredited by FDA to operate a system for the 
issuance of UDIs. 
Labeler  Any person who causes a label to be applied to a device with the 
intent that the device will be commercially distributed without 
any intended subsequent replacement or modification of the 
label; and, any person who causes the label of a device to be 
replaced or modified with the intent that the device will be 
commercially distributed without any subsequent replacement or 
modification of the label, except that the addition of the name of, 
and contact information for, a person who distributes the device, 
without making any other changes to the label, is not a 
modification for the purposes of determining whether a person is 
a labeler. 
Labeler Data Entry  Individual(s) responsible for day to day entry, submission and 
(LDE) User  management of device identification information for designated 
Labeler DUNS into the GUDID. 
Listing Number  Number assigned by FDA during Registration and Listing to all 
devices in commercial distribution, regardless of pre-market 
authorization requirements per 21 CFR 807.28(f) 
New DI Trigger  Attributes, which when changed, no longer represent the same 
Attributes  device thereby requiring the creation of a new DI. 
Package  According to 21 CFR 801.3, a package is defined as a fixed 
quantity of a particular version or model of a device. 
Package DI  A device identifier for the package configuration that contains 
multiple units of the base package (does not include shipping 
containers). 
Primary DI  An identifier that is the main (primary) lookup for a medical 
device and meets the requirements to uniquely identify a device 
through its distribution and use. The Primary DI would be 
located on the base package, which is the lowest level of a 
medical device containing a full UDI. For medical devices 
without packaging, the Primary DI number and full UDI may be 
on the device itself. 
Product Code  Three letter classification code for pre-market devices issues by 
FDA. 
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Term  Description 
Production  A conditional, variable portion of a UDI that identifies one or 
Identifier(s) (PI)  more of the following when included on the label of the device: 
(i) The lot or batch within which a device was manufactured; 
(ii) The serial number of a specific device; 
(3) The expiration date of a specific device; 
(iv) The date a specific device was manufactured. 
(v) For an HCT/P regulated as a device, the distinct identification 
code required by  1271.290(c). 
Published DI Record  A DI record that is published, and therefore is available for 
search and retrieval by the public. 
Regulatory Contact  Individual responsible for management of GUDID submission 
requirements for the Labelers in a given GUDID account. 
Relabler  Relabeler, for the purposes of 21 CFR 830.60, is a new labeler 
that changes the content of the labeling from that supplied from 
the original labeler for distribution under the new labeler's own 
name. A relabeler does not include labelers that do not change 
the original labeling but merely add their own name. 
Secondary DI  An identifier that is an alternate (secondary) lookup for a medical 
device that is issued from a different issuing agency than the 
primary DI. 
Structured Product  A HL7 standard for the exchange of product information using 
Labeling (SPL)  extensible markup language. 
Support Contact  Contact for consumers and healthcare providers to obtain 
additional information about the device. 
Third-party submitters  Companies/individuals (contractors, vendors) authorized to 
submit GUDID information on behalf of the Labeler. 
Unique Device  A unique numeric identifier composed of the device identifier 
Identifier (UDI)  and production identifier(s) that uniquely identify a medical 
device through distribution and use.  
Unit of Use DI  An identifier assigned to an individual medical device when a 
UDI is not labeled on the individual device at the level of its unit 
of use. Its purpose is to associate the use of a device to/on a 
patient. 
Unpublished DI  DI record that has passed GUDID business rules AND 
Record   Publish Date > today. 
 
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