FDA

Need Help Navigating UDI? FDA Can Help

By MedTech Intelligence Staff
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FDA

The agency has posted new education modules about the unique device identification rule.

Although the unique device identification (UDI) rule was finalized in September 2013, the compliance rollout period will last several years (based on device classification).  To help companies as the rule is phased in, FDA has posted five new education modules. Housed on the CDRH Learn section of the agency’s website, modules include:

  • Overview of UDI regulation, including its benefits, the implementation schedule and basic label requirements
  • Global UDI Database (GUDID) account creation process and how to request an account, along with understanding the roles of users and organizations
  • GUDID device identifier (DI) record requirements, including data elements and submission options related to GUDID, and understanding the importance of data quality
  • HL7 SPL submission option for GUDID, the format required, how to submit, and when the option is appropriate

The fifth education module is a workshop series consisting of two presentations (including a Q&A session) that reviews the basics of GUDID and DI record requirements, how to identity the appropriate submission option, labeling and data submission requirements, and a review of HL7 SPL.

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