Medical Devices

FDA Webinar: Global Unique Device Identification Database (GUDID) Account Set Up

This webinar will provide in-depth information on the GUDID account structure and instructions for establishing a GUDID account. There will also be an opportunity to ask questions regarding the GUDID. Please note that this webinar is specifically targeted to manufacturers of class III medical devices, who must comply with UDI requirements for these devices by September 24, 2014.

Prior to this webinar, we highly recommend participants view the GUDID Overview webinar.

DATE: Thursday January 30, 2014
TIME: 12:30 p.m. EST

Presenter: Indira Konduri, OSB/CDRH/FDA

To Participate and ask questions: 888-469-2977

To View the Slides during the webinar:

URL: https://www.mymeetings.com/nc/join/ disclaimer icon
Conference number: PW3969412
Audience passcode: CDRH

Participants can join the event directly at:
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Following the webinar the slides, audio recording and written transcript will be available on the CDRH Learn section of FDA.gov.

FDA Webinar: Global Unique Device Identification Database (GUDID): Account Set Up      

BACKGROUND: On September 24, 2013, the FDA released the final rule for the Unique Device Identification System requiring that the labels and packaging of most medical devices distributed in the United States bear a unique device identifier (UDI). As part of the UDI system, device labelers must submit data to the FDA-administered Global Unique Device Identification Database (GUDID), which will serve as a reference catalog for each device with a UDI. In addition, the FDA released a draft guidance, Global Unique Device Identification Database (GUDID) that provides information to labelers about what and how to submit data to the database. At this time, only labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act (PHS Act) may obtain a GUDID account and submit data to the GUDID.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 06/24/2014
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