Unique Device Identification: Direct Marking of Devices

Last month the FDA released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”, intended to help medical device labelers understand the FDA’s requirements for direct marking of devices for unique device identification purposes.

A unique device identifier (UDI) is required to be directly marked on a device itself if the device is required to bear a UDI on its label, and is also intended to be used more than once and reprocessed before each use. Because these devices are typically separated from their original labels or packages bearing UDIs, directly marking them with a UDI assures adequate identification.

Upcoming UDI compliance dates are:

  • Class I, class II, and unclassified implantable, life-sustaining, or life-supporting devices must comply with the UDI labeling and GUDID submission requirements by September 24, 2015.
  • All life-sustaining or life-supporting devices must comply with the UDI direct marking requirements by September 24, 2015.

Lernia is now offering an eLearning course that will help you become familiar with the dynamics involved in the medical device industry when implementing the Unique Device Identification regulations. Course lessons include:

  • History of UDI Regulations
  • Classification of Medical Devices
  • Key UDI Principles and Compliance Deadlines
  • Overview of GUDID
  • Key Implementation Questions

For more information, and to purchase a copy of our UDI eLearning course, visit our Products page.

Compliance Training: Unique Device Identification (UDI)

Implementing UDI at your company and need employee compliance training on UDI? Purchase and customize this 25-minute UDI Overview eLearning course for your organization.

This online course will help your employees become familiar with UDI regulations within the medical device industry, and key considerations that an organization should know when implementing UDI.

Customize the course with your organization’s:

  • Logo and color branding
  • Key internal messaging
  • Learning Management System (LMS) standards to track course completion

Benefits:

  • Minimal ramp up time to provide training to your organization
  • Low costs to purchase the course (source content included)
  • Short time to implement on your company’s LMS for tracking purposes

No User Fees * No License Fees * No Ongoing Commitment

By the end of the course, your employees will be able to:

  • Recognize the origin and historical timeline of UDI regulations for medical device manufacturers
  • Explain the different classifications of medical devices
  • Identify key UDI principles and compliance deadlines for implementation of UDI in your organization
  • Recognize general submission requirements to the Global UDI Database
  • Discuss key considerations when implementing the adoption of UDI across your company

If you are interested in purchasing or customization of this UDI Overview module for your organization, call 610.356.1792 or e-mail us at lernia@lernia-ts.com.

UDI eLearning Module

Lernia Training Solutions has recently completed an eLearning module that introduces medical device colleagues to the recently approved guidance from the FDA regarding UDI. The 20-minute module will help learners become familiar with the dynamics involved for the medical device industry, and key considerations that an organization should know when implementing the UDI regulations.

By the end of the course, learners will be able to:

  • Recognize the origin and historical timeline of UDI regulations for medical device manufacturers
  • Explain the different classifications of medical devices
  • Identify key UDI principles and compliance deadlines for implementation of UDI in your organization
  • Recognize general submission requirements to the Global UDI Database
  • Discuss key considerations when planning the adoption of UDI across your organization

Play a short video clip to get a glimpse of UDI Overview or select the corresponding link if you are interested in receiving a complimentary full version of the UDI Overview.