Medical Devices

CDRH Industry Basics Workshop - Unique Device Identification (UDI) Part II, Submitting Information to GUDID, March 10th, 2016

Summary: This workshop (presented by webinar) will provide information on the fundamental concepts of how to submit information into the Global Unique Device Identification Database (GUDID). This workshop is the second of our two-part UDI Industry Basics.

The workshop features two sessions, each consisting of a presentation followed by a question and answer session with a panel of experts from the Office of Surveillance and Biometrics. Participants can email or call with questions during each session’s Question and Answer session.

Participants may choose either or both sessions. Each session will begin at the scheduled time.

1:00 – 2:15 PM – GUDID Device Identifier Record
2:15 – 3:00 PM – HL7 SPL Submission Option

Target Audience: Class II Labelers, other than Implantable, Life Supporting, and Life Sustaining Devices.

There is no fee to attend and registration is not required.

How to Join the Workshop: All participants attend via webinar, which will be at: http://fda.yorkcast.com/webcast/Play/a21960fcc6d44a3380eba129a069cfd81d

The March 10th, 2016, CDRH Industry Basics Workshop is not intended to provide submission-specific feedback, so please limit your questions to broad policy questions about the program topics. Submission-specific questions will be referred to the appropriate CDRH program Office for response.
 

Page Last Updated: 04/07/2016
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