On June 7 and 8, the medical device industry joined the FDA for the ninth Annual UDI Conference. With a recent UDI extension for Class I device labelers, industry members had an increased interest in FDA’s commentary on the state of the UDI mandate. During the two-day session, FDA provided valuable insight into their main goals surrounding the UDI initiative.
Focus on Data Quality
Behnaz Minaei, GUDID Data Quality Lead at FDA, noted, “It costs about $1 to verify a record as it’s being entered in the system, 10 times as much to correct it and 100 times as much to not correct it.”
Labelers of Class III and II medical devices have often struggled with unclear compliance requirements for GUDID data attributes. In recent months, the FDA has contacted labelers of submitted UDI records following an evaluation of inaccurate data attributes. During the conference, Minaei provided a top ten list of the attributes with the largest number of errors:
- Brand Name
- Catalog Number
- MRI Safety
Device labelers should take special care to ensure accuracy in these fields. Minaei suggested that labelers verify data across business and FDA data sources, as well as pay increased attention to the consistency and completeness of data submitted to the GUDID.
Up for Discussion
Minaei invited feedback from industry on several proposed GUDID record status updates. First, she mentioned that FDA is considering reducing or eliminating the Grace Period (currently 30 days) following the DI Record Publish Date.
In addition, Minaei revealed a proposal to add a new DI Record Status value called “Edit.” This new status would appear when a labeler must make a change to a data attribute that previously could not be edited under the current rules when a record reaches “Publish” status. Records in Edit would still appear within AccessGUDID, along with the updated status. Today, labelers requesting changes to published records must contact the GUDID Help Desk and request that the record be unpublished. The Edit status would allow the public to view the record while alerting viewers of potentially erroneous data.
Impact for Class I Labelers
FDA emphasized the additional time allowed should be used by the industry to begin the process now. Class I labelers in attendance noted they plan to begin working on Class I submissions immediately. Since the FDA is increasingly focused on data quality and accuracy, it is essential that labelers take the time to thoroughly collect data from internal sources, check all values against internal and FDA sources, and validate the data attributes in accordance with FDA business rules.
Were you unable to attend the conference and are unsure what the implications of the FDA’s message are for your organization? Or maybe you were there but want to discuss these developments in more detail and plan your approach for moving forward with UDI compliance. Contact the Reed Tech team to think through the next steps for your organization. We will be happy to help you along the path to UDI success.