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FDA Launches Searchable UDI Database

FDA has launched the database that links the cumbersome unique device identification (UDI) process for manufacturers to quick, public tracking of their medical devices.

The Global Unique Device Identification Database (GUDID), created in collaboration with the National Library of Medicine, allows users to search for and download information submitted by device manufacturers. Filters include device identifier, company name, device brand name, device common name and device version/model number. The results provide a description, characteristics and status of medical devices.

Data is updated daily with the most recent submissions received by FDA. More than 51,590 device identifier records have been uploaded to the database.

FDA released the final rule on UDI in September 2013. Presently, data on Class III medical devices is being submitted, in line with UDI’s system of phasing in the different classes. As each category complies with the UDI requirements, those records will be incorporated into the database.

The site is in beta test mode and FDA invites feedback from users.

FDA developed the UDI system to provide a standard way to identify devices, from manufacturing through the supply chain to patient use. UDI has the potential to assist with improving patient safety and modernizing postmarket surveillance.

More BONEZONE articles on FDA:
Unique Device Identification: Many Questions Remain
FDA Publishes Q&A on UDIs
CAPA+2, UDI and More: What to Expect from FDA in 2015

Don’t forget --The deadline for
UDI implementation of implantable, life-supporting or sustaining devices is
September 24, 2015.

Get answers to your implementation questions at OMTEC 2015:

UDI: The Ins and Outs of Global Compliance and Value

UDI: Uncover and Overcome Challenges Facing Orthopaedics

FDA will also be on site to
answer your questions.

Presentations include: 

FDA Update: What's New in Orthopaedic Devices?

FDA Advises on How to Improve Your 510(k) Submission Process