Please note, this is Part Two of a two-part blog on the 2018 UDI Conference. You can read Part One here.
FDA Makes GUDID Changes to Improve Data Quality
Throughout the UDI Conference, FDA representatives continued to drive home the message of their 2018 data quality campaign during multiple sessions. In particular, Indira Konduri of the FDA detailed the changes her team is making to editing rules in an effort to improve the quality of the data in GUDID. You can read in more detail about FDA’s updates to the GUDID editing rules in our recent blog here.
FDA representatives also detailed several new fields available within the download files and device records in AccessGUDID, the National Library of Medicine’s public portal into the UDI database. These fields, previously contained within GUDID but inaccessible to the public, include:
- Labeler D-U-N-S® Number
- Public Device Record Key
- Public Version Number
- Public Version Date
- Public Version Status
They have been added to AccessGUDID to improve the accessibility and value of the data to downstream users. There is also a new Device Record History Table with XML download options, so the changes made to a device record over time and previous versions are publically available.
Though many of the details in FDA-led sessions were previously disclosed to industry members through other channels, the agency announced some important new details for the first time to the larger audience in Baltimore:
- GUDID Version 2.3 is tentatively scheduled to release on June 15.
- A new validation rule for the GS1 GTIN Check Digit will be added. Previously, a GTIN with an invalid check digit could be successfully loaded into the GUDID.
- Additional terms will be added to controlled vocabulary for Clinically Relevant Size to accommodate various device types.
- DI Record Premarket Submission and Supplement numbers will be made publically available, based on the confidentiality designations in the Device Registration and Listing (FURLS) system.
The release of DI Record Premarket Submission and Supplement numbers within the GUDID means device labelers should review their FURLS records to ensure that any confidential information is marked appropriately. Once these fields are published, they will continue to appear as part of the device history, even if changes are made in FURLS to the confidentiality designation. However, in order to ensure the value and fullness of the data downstream, labelers should only mark information as confidential if they have a compelling business reason for doing so.
Manufacturers Grapple with New Data Challenges
As end users of UDI data begin to leverage device record data downstream, FDA continues to learn more and receive feedback about the various use cases and applications for the data it’s been collecting. As it receives feedback from industry members and data users, the agency has instituted some changes in an effort to yield better, richer data.
As an example, FDA had previously provided instructions to device labelers that they should enter “NA” in the Brand Name field if the device has no brand name. However, after receiving feedback from data users, the agency has now begun to advise labelers to “enter the name commonly used to refer to the device or family of devices” and not to enter “NA, N/A, Not Applicable or any other similar term.”
Industry members had lots of questions for FDA surrounding this topic and how it would apply to particular device records. Similar questions arose about how to properly enter data surrounding devices sold as kits. FDA representatives were unable to provide immediate resolution to all outstanding questions about these fields, but it was evident that the agency and industry continue to grapple with how to ensure the most accurate, useful and complete data is collected.
UDI Goes to Europe and Beyond
Though data quality was a topic touched on during nearly every conference session, it was not the only topic to pique the interest of the wider audience. With just over two years before EU MDR comes into effect throughout Europe on May 26, 2020, industry members were eager to deepen their knowledge of what MDR, especially its UDI provisions, will mean for their organizations.
While too broad of a topic to address here, UDI in Europe deserves its own series. Stay tuned for more EU UDI blog content from Reed Tech. In the meantime, you can review slides from Jay Crowley’s conference presentation on UDI in the EU here. You can also register for a free upcoming webinar hosted by Reed Tech, along with our friends at PRISYM ID, EU MDR’s Impact on Labeling: UDI in Europe and Other Changes.
Beyond the EU, UDI or UDI-like data collection initiatives are underway in the UK, Turkey, Taiwan, China, Japan, India, Saudi Arabia and other countries, as well as among non-governmental entities such as GPOs and major device buyers. Far from the finish line, FDA’s Class I deadline in September 2020 represents the beginning of the UDI journey.
As you’ve probably realized by now, UDI keeps getting deeper and wider as it evolves. Device organizations, especially those competing in global or multinational markets, will need to understand this evolution and form a plan for managing their product data and syndicating it to all of the end users who need it. If you’re overwhelmed and need help developing a strategy for managing and sharing your product data, contact the team at Reed Tech. We’ll be happy to help.