The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID Services). The document is intended to provide medical device manufacturers and other parties involved with additional clarifications to be considered to ensure compliance with the applicable regulatory requirements. At the same time, the guidance is not intended to introduce new rules and requirements, and all the provisions contained therein are non-binding. Moreover, the authority states that an alternative approach could be applied, provided such an approach complies with existing legislation and has been agreed with the regulating authority in advance.
GUDID Modules: Key Points
As it was mentioned before, the guidance highlights the most important aspects associated with the GUDID and the way the information should be submitted by the responsible parties. The document describes, among other things, the GUDID Modules, and also outlines core elements related thereto.
Under the general rule, there are two ways the information related to medical devices could be submitted to the database:
- Submission of one DI record at a time via the secure GUDID Web Interface;
- Submission of one DI record per XML file via the HL7 SPL submission option.
As further explained by the FDA, the appropriate GUDID account is required for each of the above mentioned options. In this regard, it is important to mention that the account is not linked in any way to the submission type, hence, the same account could be used for both types of submission. The main purpose of a GUDID account is to identify the entity submitting information about a medical device it is responsible for. The scope of the present FDA guidance covers both submission options, so the recommendations provided therein could be applied in all the cases, unless otherwise explicitly stated by the Agency.
At the moment, the only function available is to search for the information related to a medical device using the appropriate web interface. However, the authority also mentions that additional functionality would be added later – for instance, the possibility to download information in a structured way, or additional web services. However, it is not mandatory to have a GUDID account to access the search function.
The authority additionally emphasizes that during the initial implementation, GUDID Public Search will be temporarily disabled until a meaningful dataset of DI records has been created.
GUDID Web Interface
The first GUDID element described in the guidance is the GUDID Web Interface. According to the document, this component could be used for:
- Creation of GUDID accounts;
- Submission of DI records; and
- Search and retrieval of device information.
The GUDID Web Interface contains several modules. The first one is the Device Identifier Module, which allows creation and management of DI records by the respective users. According to the guidance, by the virtue of this module, the users can:
- 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 (this is different for public search users who can only view attributes indicated “public” in the Data Elements Reference Table).
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The guidance further describes in detail the main functions of the DI Module including, inter alia, creating new records, editing drafts, unpublished and published records, as well as making copies.
As explained by the FDA, the whole process commences with the creation of a new DI record. The authority additionally mentions that a draft DI record could not be created by the virtue of the HL7 SPL submission. A draft would later be saved and reviewed. Then, the status of the entry could be changed to “Unpublished” or “Published”. The document also contains a flowchart describing the whole process in detail step-by-step. According to the flowchart, once a new record is created, the functions that become available to a user include “Save”, “Cancel”, and “Review”.
About the submission process the authority additionally emphasizes that submission of the information to the database should not be construed as sufficient to fulfill the respective requirements, while to complete the process, a responsible entity should ensure the appropriate DI record is duly published.
While a DI record is in process, it could be saved as a Draft DI record. To be saved as “Unpublished” or “Published”, it should pass business rules. It is also important to mention that in case no further actions are taken, a Draft DI record that remains inactive for more than 180 days would be removed from the system entirely. However, each time such a record is subject to any editing and changes, the calculation of the aforementioned term starts from the very begging of the respective editing date.
HL7 SPL Submission
The second submission option available for all users having GUDID accounts is the HL7 SPL Submission, which allows submitting information as an XML file. Before using this option for actual submission, a responsible entity should conduct testing to ensure the system operates as intended. As it is mentioned in the guidance, it is also allowed to appoint third-party authors authorized to file submissions on behalf of the entity responsible for labeling. Should this be the case, then appropriate testing should be conducted as well to assess the functionality.
Search/Retrieval of Device Information
One of the main functions available at the moment is provided by the GUDID Search and Retrieval module which allows public users (the ones having no GUDID accounts) to access information stored in the database. According to the guidance, by the device of such search, they would be able to access all publicly available information. This includes all DI record attributes with a few exceptions such as Labeler DUNS Number, Company Physical Address, GMDN Preferred Term Code, FDA Listing Number, etc. However, as it was mentioned before, this function would be disabled for a certain period.
According to the guidance, the search-related options available in the system are:
- Search and retrieval of device information via the Web Interface,
- System to system search and retrieval.
In summary, the present FDA guidance describes the main functions currently available concerning the data stored in the GUDID and also provides additional information regarding the GUDID Modules. The document outlines key points regarding the way GUDID users and non-registered public users could interact with the system now, and which functions would become available at a later stage of the system development.