The FDA’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products.
In final guidance issued June 27, the agency makes multiple minor changes to earlier guidance on establishing the database. For example, one change concerns the formatting of MRI safety information.
While the changes are small, they will create additional challenges for devicemakers who are in the midst of tracking down, validating and completing information for GUDID database entries, says Jay Crowley, UDI practice lead at USMD Life Sciences and formerly the FDA’s top UDI official.
“UDI information gathering has been a Herculean effort for most manufacturers,” Crowley said. “And it’s caused quite a bit of angst on the part of manufacturers because the list of attributes can’t be a moving target.”
But the guidance provides welcome detail in other areas, Crowley says, filling in details about how to create GUDID data that satisfies the electronic records requirements of 21 CFR Part 11 and details on use of the Global Medical Device Nomenclature (GMDN) search module. Crowley describes those sections as “very good additional new information.”
The guidance, which supersedes final guidance issued just two weeks earlier, provides a step-by-step roadmap for establishing a GUDID account, GUDID user roles and device identifier records. Manufacturers of Class III implantable devices must begin complying with UDI requirements on Sept. 24.
Key to using GUDID is understanding the lifecycle of a DI record — the device identifier and its associated data attributes. At any given time, the DI record exists in one of three states: draft, unpublished or published, according to the guidance.
Creating a draft DI record allows companies to prepopulate and save a record via the GUDID web interface. “Users may also create Draft DI records to get familiar with creating and saving DI records in GUDID,” the guidance notes, adding that users should “not submit records for publishing when created solely for the purpose of familiarizing yourself with the system.”
Each DI record is also subject to GUDID business rules to ensure data quality and conformance to standards, and draft DI records must pass review under the business rules before being submitted to GUDID. Business rules for each data element are provided in the GUDID Data Elements Reference Table, the guidance notes. After that, the record exists either in an unpublished or published state, the guidance says. A published DI record is one that has passed all business rules and is subject to editing limitations, based on the seven-day grace period that starts the day after the DI record is published.
For purposes of the DI, a device package comprises “a fixed quantity of a particular version or model of a device.” Each different type of package must have a unique identifier, the guidance notes. “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,” the FDA explains.
The guidance also outlines steps for obtaining an account and managing account changes. The FDA points out that during initial implementation, GUDID Public Search will be temporarily disabled until a meaningful dataset of DI records has been created.
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