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FDA Update and Q&A: UDI

 

As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:

  • How does FDA recommend we direct mark screws and small implants?
  • How should we proceed as we await the guidance on the Convenience Kit exemption?
  • What are best practices for entering submissions to GUDID?
  • How is FDA enforcing UDI?

FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.

Terrie Reed, Senior Advisor for UDI Adoption, FDA
Terrie Reed webTerrie Reed recently returned to FDA as Senior Advisor for UDI Adoption after a one year opportunity to work with experts in device informatics research at Duke Clinical Research Institute. Ms. Reed has spent her career advocating for the operational integration of data standards and informatics principles into healthcare and government systems in order to improve the efficiency of regulatory submissions and public health reporting. Her latest role as Senior Advisor for UDI Adoption is the culmination of years of systems analysis, information science, and regulatory science experience aimed at significantly improving device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem. She has a Master’s in Industrial Engineering.
 
Behnaz Minaei, Data Quality Lead, GUDID
Please check back for a bio.