The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to Unique Device Identifiers. Apart from other aspects, the guidance covers the matters related to GUDID. Due to its legal nature, the guidance is non-binding, as is not intended to introduce new rules and requirements, but to provide additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved. Moreover, an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been agreed with the authority in advance.
The aspects covered by the guidance include, inter alia, the following ones:
- GUDID account and user roles;
- Device identifier record;
- The device identifier records the life cycle.
The authority also mentions that the aspects covered by the guidance are applicable for both types of submissions.
Table of Contents
GUDID Account: Basics
As it was mentioned before, to be able to submit information, an interested entity should have a GUDID account. To assist medical device manufacturers and other parties responsible for placing labels on medical devices, the guidance provides additional details regarding the account, user roles, and the way the account could be obtained and managed. In this regard, the authority states that an entity is entitled to have several accounts. The guidance highlights the following key points associated with the account:
- An entity responsible for placing labels could be identified by the device of a DUNS number, which constitutes an important element of the FDA Unique Facility Identifier System containing, inter alia, precise information about the location of the manufacturing site.
- The entities are responsible for ensuring the accuracy of data contained in the respective databases, including the name and address.
- All GUDID accounts should have an Organisation DUNS Number associated thereto (key features of the number: it is associated with the headquarters of an organization, connected with the name and address indicated in the respective database, could be used only once, including the use of a Labeler DUNS number).
- The account should be associated with the respective Regulatory Contact, which should be only one (for the guidance, a Regulatory Contact stands for the individual who serves as the point of contact to [the FDA] 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). The authority also mentions that the Regulatory Contact serves as the highest point of contact for all regulatory matters, but does not have access to GUDID. However, if the Regulatory Contact serves as GUDID Coordinator and Labeler Data Entry user, he/she will have a respective account in the system. It is also stated that a third party could be engaged as the Regulatory Contact. In such a case, the appropriate official letter should be issued by the responsible entity.
- The authority additionally emphasizes that to ensure data consistency the company name associated with the Labeler DUNS number should match the company name that appears on the device label, while the Labeler DUNS number, once used, cannot be reused in any other GUDID account.
Another important key person described in the guidance is a Coordinator. According to the guidance, one or several of them could be appointed. As further described by the FDA, the scope of responsibilities of a Coordinator include, inter alia, the following ones:
- Create Labeler Data Entry (LDE) User account(s);
- Assign Labeler DUNS number(s) to LDE(s);
- Create LDE User role for a third-party, if so desired;
- Serve as Regulatory Contact, if so desired;
- Serve as LDE user, if so desired; separate username and password is provided for the LDE user role;
- Service 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.
It is important to mention that several Coordinators could be simultaneously responsible for a single Labeler DUNS Number.
Features and Functions
As described hereinabove, to submit information to the respective database, an appropriate GUDID account is needed. One account could be associated with several LDE Users allowed to submit and modify information used to identify a medical device placed on the market. Such a user could be a Regulatory Contact or Coordinator user – for the latter case, separate login credentials should be used. The same as in the case with Coordinators, several LDE Users could be jointly responsible for a single Labeler DUNS Number.
In terms of access to the database, the authority also mentions that it is allowed to appoint third parties to submit information to GUDID on behalf of the entity responsible for placing labels on the device. At the same time, the FDA additionally emphasizes that the label remains responsible for the information submitted. The guidance further describes specific aspects of third party involvement associated with the different types of submissions:
- In case of submission via the Web Interface, such a third party will have access to submit the information on behalf of the labeler grating such an authorization;
- In the case of HL7 SPL submissions, under the general rule, the possibilities of a third party would be limited to generating the appropriate HL7 SPL file which later should be submitted by the labeler itself. However, in certain cases, a third party could also submit the HP7 SPL file for the labeler. For this purpose, the respective DUNS number should be communicated by the responsible entity to the third party engaged, and the latter should be associated with the account of the labeler, otherwise, the request will be rejected.
The authority also mentions that contact details of the Regulatory Contact, Coordinator, and LDE user would not be publicly available.
The accounts are not related to submission types – hence, should the labeler decide to change the type of submissions used, there would be no need to create a new account, as the latter is used merely to identify the entity responsible for labeling, and not the submission type, which could any of the two described in the respective guidance.
As described hereinabove, a GUDID account is needed to be able to submit information to the respective database and modify information already contained therein. However, such an account is not needed to be able to search.
In summary, the present guidance covers the most important aspects associated with GUDID accounts. The document highlights the regulatory matters associated with the regulatory status of the main responsible persons, including Regulatory Contact and Coordinator.
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