UDI-Issuing Agency Recommends Four Steps to Achieving Compliance

May 23, 2014

As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice.

Speaking at the Food and Drug Law Institute annual meeting in Washington, D.C., Siobhan O’Bara, senior vice president for industry engagement at GS1 US, outlined four steps manufacturers should follow to put UDIs in place before their appointed deadlines:

  • Develop standardized UDIs;
  • Put UDIs on product labels in both a human readable format and automatic identification and data capture, or AIDC;
  • Submit the metadata to the FDA; and
  • Be sure to follow implementation timelines.

For manufacturers of Class III devices, the deadline for having UDIs on product labeling is Sept. 24.

Companies can submit metadata in one of two ways, O’Bara noted. A company with only a few products may opt to enter the information item by item via an online portal. Larger companies may choose a flat file upload, where a spreadsheet is updated to the FDA. The agency has established rules to ensure these uploads meet data quality standards.

O’Bara reminded devicemakers that existing inventories are exempt from UDI requirements. Device and diagnostic kits fall under specific provisions of the rule, but still must be marked with a UDI. As with all devices, the UDI must exist on every level of kit packaging, she said.

Companies don’t need to update UDIs for every batch of a device, O’Bara stressed. The FDA has published a list of 23 attributes that, if altered, would trigger a UDI update. These include country of origin, presence or absence of latex in a product and sterility of the packaging.

O’Bara urged manufacturers to start gearing up early for UDI implementation, as it is “no small undertaking.” The identifiers may need to be factored into multiple types of manufacturing software, software used for device sales, and legacy systems, she said.

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