As medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device Identification requirements, one of the prerequisite steps for all manufacturers is to establish a Global Unique Device Identification Database account. Requesting a GUDID account from the FDA and correctly setting it up requires planning and organization. Follow these five steps to ensure successful completion of the process.
1. Decide how many GUDID accounts are needed.
Each account identifies a separate Labeler Organization, typically the corporate headquarters. Depending upon its organizational structure, a device manufacturer may opt to request one or multiple accounts. Small and medium-sized manufacturers usually require only one account. Large companies might request a single account for all their products or opt to create multiple accounts dedicated to different segments of their portfolio, e.g., divided by subsidiaries.
Each account also includes a list of Labeler companies that will be used by the FDA to segregate the data. Both Labeler Organizations and Labelers must be identified in the account application with their Dun & Bradstreet DUNS number. Once identified as a Labeler Organization and/or a Labeler on an account, a company’s DUNS number cannot be reused in any other account.
2. Decide how to submit data to FDA.
The next step is to evaluate your data volumes and choose a method of submission. The FDA has made available a GUDID web interface, which allows device manufacturers to enter data into the database manually. Though there is no cost to access the web interface, each company will shoulder the cost of the staff time required to enter and check the data. In practice, the web interface is a good option only for companies with a small number of records to submit.
Companies with larger product portfolios are likely to choose to submit their data in Structured Product Labeling format. To convert data into submission-ready SPL files, device labelers will need either to purchase/build software or work with a third-party provider like Reed Tech for help through the process. Any third parties that submit data to the FDA under a Labeler Organization’s GUDID account must be identified by their DUNS numbers on that account.
3. Identify GUDID account personnel.
Each account has one Regulatory Contact who is ultimately responsible for ensuring that all data the company submits meets the FDA’s requirements. The Regulatory Contact is associated with the account only in an informational capacity and does not automatically receive account access. This person may also serve as a Coordinator User or Labeler Data Entry User, but those roles must be set up separately and are unrelated to their Regulatory Contact role.
An account may have multiple Coordinator Users who are assigned to one or more Labeler companies listed on the account and are responsible for the management of those Labelers’ submissions. Similarly, an account can include an unlimited number of Labeler Data Entry Users whose access permits them to handle the day-to-day work of submitting data. A Coordinator User has the ability to create Labeler Data Entry Users as needed. A Coordinator User may also serve as a Data Entry User, but will have separate accounts for each role.
4. Request a GUDID account.
Device manufacturers may then request an account from the FDA by submitting the following information:
- The DUNS number, company name, and address of the Labeler Organization. For large companies, this should be the highest corporate level in the organization, e.g., the headquarters.
- The name, email, phone number, and address of the Regulatory Contact for the Labeling Organization.
- The DUNS numbers, company names, and addresses of Labeler companies that will be submitting device records to the GUDID.
- The names, emails, and phone numbers of the Coordinator User(s) on the account and the assigned Labeler DUNS numbers they can access.
- The DUNS numbers, company names, and addresses of any third-party submitters.
- The preferred submission type: Web Interface or SPL. Selecting SPL as the primary submission type will also allow use of the Web Interface.
- One FDA Premarket Application number. The FDA will verify this entry is valid.
The FDA will review the account application and, if approved, will email instructions for accessing the account.
5. Test the SPL submissions.
Device manufacturers that want to submit data in SPL format must complete testing to ensure their submissions flow through the Electronic Submissions Gateway (ESG) and are successfully imported. The FDA provides SPL submitters with a separate test account prior to the production account. The test account should be used to evaluate the SPL submission procedure using the FDA’s test scenarios and a representative sample of the company’s products. The device manufacturer must email the Core IDs of those test SPL submissions to the FDA Help Desk along with a new Account Request Form. Upon approval, the FDA will then provide access to a production account.
FDA recommends that manufacturers prepare for GUDID compliance by establishing an internal action plan and a timetable for submission. Following the steps above will set a manufacturer on the path to compliance, but each of these steps takes time. For example, all DUNS numbers must be identified and, if any of the submitting entities do not have a DUNS number, they must obtain one. Though the numbers are issued by Dun & Bradstreet at no cost, the process can take up to 30 days.
DUNS number assignment is just one of many steps to complete as medical device manufacturers implement the changes necessary for UDI compliance. Bringing together key decision-makers early in the process and starting the submission process early will enable manufacturers to deal with those factors with plenty of time to spare before their compliance deadline.