Summary: This workshop (presented by webinar) will provide information on the fundamental concepts of Unique Device Identification and how to prepare for and request a GUDID account.
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 chose one or both of the sessions. Each session will begin at the scheduled time.
1:00 – 2:00 PM – Unique Device Identification (UDI) System Regulatory Overview
2:00 – 3:00 PM – GUDID Account Request: Preparation and Process
Target Audience: Medical Device Industry, Medical Device Industry Associations, 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, see link below
The January 27, 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.