Announcing Five New Unique Device Identification (UDI) Education Modules

Today, the Food and Drug Administration posted five new medical device education modules to the CDRH Learn Program website. The CDRH Learn website has also been improved to allow easier navigation of the Unique Device Identification (UDI) System section.

What is CDRH Learn?
CDRH Learn is an innovative multimedia catalog of online educational modules intended to provide information about medical device laws, regulations, and policies that is comprehensive, interactive, and easily accessible. The format for each topic is chosen to present the information in the most effective way possible.

What is Unique Device Identification (UDI)?
FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. The Unique Device Identification (UDI) rule became final in September 2013 and is being phased in over several years based primarily on device classification. When fully implemented, the UDI System will offer a range of benefits to industry, FDA, consumers, health care providers and health care systems including improved patient safety and postmarket surveillance.

New Modules

Four new modules can be found in the CDRH Learn Section “Unique Device Identification (UDI) System”

CDRH Learn Module Title	Key Learning Objective(s)
1. Unique Device Identification (UDI) System Regulatory Overview	Understand the UDI regulation and basic UDI labeler requirements. Learn label and date format requirements Understand the UDI implementation schedule Learn about the benefits of UDI
2.  Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process	Understands the basics of the GUDID account creation process and how to request an account Learn about the information required to create an account Understand the different roles of  users and organizations
3.  The GUDID Device Identifier (DI) Record	Understand the basic DI record requirements Learn about GUDID data elements   Learn about GUDID submission options Understand the importance of data quality
4.  HL7 SPL Submission Option	Understand the basics of the HL7 SPL submission option for GUDID   Identify when this option is appropriate Learn the format required for it, and understand how to submit HL7 SPL information

The fifth new module is located under the CDRH Learn Section "Industry Basics Workshop Series” and consists of two presentations each followed with a moderated question and answer session

CDRH Learn Module Title	Key Learning Objective(s)
March 2016 Industry Basics Workshop - Unique Device Identification (UDI) Part II, Submitting Information to GUDID	Understand the basics of GUDID and DI record requirements Learn how to submit information to GUDID Identify what submission option is appropriate for you Learn label and data submission requirements Learn the requirements for using the HL7 SPL submission option and how to submit using HL7 SPL

For more information about the Unique Device Identification (UDI) System, please visit the FDA’s UDI webpage.

For Information about Medical Devices
If you have any questions about CDRH Learn, or medical devices in general, contact the Division of Industry and Consumer Education (DICE):

• Phone: (800) 638-2041 or 301-796-7100; 9 am - 12:30 pm and 1:00 pm - 4:30 pm Eastern Time
• Email: DICE@fda.hhs.gov

Please visit us at our website for more information about how we can help you.

Thank You,

Food and Drug Administration
Center for Devices and Radiological Health