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). The document highlights the most important aspects related to the GUDID and is intended to provide additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved. It is important to mention that due to the legal nature of the guidance provisions contained therein are non-binding, nor intended to introduce new rules and requirements. The authority also states that an alternative approach could be applied, provided such an approach complies with existing legislation and has been agreed with the Agency in advance.

GUDID Account: Key Points 

Among other aspects, the document provides additional clarifications regarding a GUDID account needed to be able to use the system – for instance, to submit new information to the database. The present FDA guidance covers the most important points related to a GUDID account, including the way it could be obtained and accessed, as well as its structure. 

According to the chart provided by the FDA, an entity responsible for placing labels (also referred to as a “Labeler Organization”) could have more than one GUDID account. At the same time, each of these accounts should be used by only one Regulatory Contact – an authorized person responsible for compliance with the respective regulatory requirements. The accounts themselves should be identified by Company’s DUNS number. The types of users include:

  • Coordinator User (responsible for the management of the GUDID account for assigned Labeler DUNS),
  • Labeler Data Entry User (responsible for the day to day entry, submission, and management of DI records for assigned Labeler DUNS),
  • Third-Party Submitted (Company/individual authorized to submit GUDID information on behalf of the labeler).

As it was mentioned before, the identification of a specific labeler entity is based on its DUNS number. This number allows connecting the company with its name and address contained in the respective database. It is important to mention that such a number always refers to the highest hierarchical level of the company (e.g., headquarters, parent company). To ensure correct identification, an entity should make sure the information contained in the D&B DUNS database is correct and accurate. The authority also mentions that once the DUNS number has been used to create a GUDID account, it could not be reused later to create another one. 

One of the most important concepts associated with GUDID accounts is the Regulatory Contact. The respective regulatory requirements are prescribed by 21 CFR 830.320(a), which states that a Regulatory Contact:

  • Is 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.
  • Is the highest point of contact for the labeler organization, i.e., [the authority] 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 a 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; both of these user roles would have a separate username and password to access GUDID. 

It is further explained that a labeler organization may decide to appoint a third party as a Regulatory Contact. In such a case, it would be necessary to notify about the decision taken when creating the account. Such a notification should be provided in the form of an official letter issued on company letterhead and signed by an authorized person. 

According to the FDA guidance, an account should be associated with one or several labelers allowed to submit information about medical devices. Hence, device-related entries would be associated with the respective DUNS numbers ensuring that the information about the company’s name and address is automatically uploaded from the respective database. The authority additionally emphasizes that the name of the company indicated on the label should match the name contained in the database. At the same time, the addresses could be different, even though the authority encourages consistency in addresses as well. 

Additional Roles 

As previously described, several user roles are having different access to a GUDID account corresponding to their functions. The first role is a Coordinator, which could be associated with one or several Labeler DUNS numbers and will be entitled to manage the account concerning these numbers. In particular, a Coordinator will be able to: 

  • Create Labeler Data Entry (LDE) User account(s),
  • Assign Labeler DUNS number(s) to LDE(s),
  • Create an 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,
  • 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. 

The FDA guidance also mentions that the responsibility for a specific Labeler DUNS number could be shared among several Coordinators. 

Another user role existing within the scope of a GUDID account is a Labeler Data Entry User. According to the guidance, one or more accounts of this type could be created by a respective Coordinator. Such an account should be used to submit and manage information related to medical devices. Apart from this, the same user could be a Regulatory Contact, and a Coordinator (in such a case, a separate username and password would be needed). The same as in the case with Coordinators, LDE Users could also share responsibility for a single Labeler DUNS number. 

 

Third-Party Submitters 

Under existing regulatory requirements, a Labeler Organization is entitled to appoint a third party to submit information about medical devices on its behalf. However, the labeler in any case remains to be fully responsible for the completeness and accuracy of the information submitted to the database. It is also allowed to appoint more than one third-party submitter. The particular way of interaction with the database would depend on the type of submission used: either Web Interface submissions or HL7 SPL submissions.

In summary, the present FDA guidance outlines the key points related to a GUDID account necessary to submit information related to medical devices to the respective database. The document describes in detail the types of user roles and clarifies their functions and actions available. 

 

Sources:

https://www.fda.gov/media/86569/download

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.


Want to know more about our solutions? Speak to a RegDesk Expert today!