UDI Working Group
Industry is faced with myriad well-intentioned rules and regulations that may prove impractical or even burdensome. The AIM NA Unique Device Identification (UDI) Working Group was developed to address industry concerns with the FDA’s recent UDI proposed rule.

The UDI Working Group’s mission is to collect member input--including expertise, guidance and best practices on the use of AIDC (automatic identification and data capture) technologies--and comment on the FDA UDI proposed rule with recommendations for the final rule adoption.

​Developing and promoting technologically and economically sensible implementation models, the working group will address the need for interoperability with national and international unique device and unique item identification requirements, emphasizing both compatibility and affordability.

The working group will also strive to educate constituents with information to facilitate a seamless adoption of UDI and SNI using AIDC methodologies.  The goal is to create a forum for open discussion of industry and FDA adoption issues and to communicate the following information:​
  • Lessons learned from past asset visibility efforts
  • Industry best practices
  • Relationships between UDI and SNI
  • UDI Return On Investment (ROI) from the end user perspective

Why UDI?​
  • Allows more accurate reporting, review & analysis of adverse event reports for problem device identification and remediation.
  • Reduces medical errors by enabling rapid and precise identification of a device and important characteristic information.
  • Enhances FDA analysis of devices on the market via a standard and clear way to document device use. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • Provides standardized identifiers allowing manufacturers, distributors and providers to better manage medical device recalls.
  • Creates a baseline for a global secure distribution chain, address counterfeiting, diversion of product, and prepares for medical emergencies logistics.
  • Leads to the development of a medical device identification system that is harmonized and recognized around the world.

What devices need to be marked?​
  • Traditional hospital-based devices, such as beds, ventilator, monitors and infusion pumps
  • Implants
  • Patient / home use devices, such as glucometers
  • Disposables and accessories, such as glucose test strips, catheters
  • In vitro diagnostic devices (IVDs), both clinical lab and point-of-care (POC)
  • Health information technology (HIT)
  • Convenience kits, combination products
  • Devices used in alternative sites, e.g., homecare, dental

Defining Medical Devices
In the US, medical devices are sorted into three risk-based classes, defined by the intended use of the device and on indications for use.

Class I
Class I devices do not support or sustain life, and include items such as tongue depressors, crutches or canes, and hand-held surgical instruments.

Class II
Class II devices require more specialized controls than Class I devices, but can be used without causing injury or harm to patient or user. Class II devices include blood pressure cuffs, oximeters, and diagnostic x-ray systems.

Class III
Class III devices support or sustain life, or are integral to the prevention and or treatment of illness or injury, requiring significant controls to ensure safety. They include items such as prosthetic joint implants, cardiac pacemakers, and HIV diagnostic tests.

  1. Work with an FDA accredited agency to develop the standardized Unique Device Identifiers.
  2. Label each device and package with the UDI in human readable and AIDC, direct marking required for devices intended to be used more than once and reprocessed before use.
  3. Submit the device’s data to the global UDI database (GUDID): Item proprietary / trade / brand name, version or model number, previous DI if applicapble, device size, production identifiers, FDA premarket submission and listing numbers, Global Medical Device Nomenclature (GMDN) term, FDA product code, and the number of devices in each package.
  4. Meet implementation timelines.

Timelines
The FDA published the Final Rule in September, 2013

Class III
  • UDI on label & package: 1 year from Rule, 9/14
  • GUDID Interface: 1 year from Rule, 9/14
  • Direct part marking: 2 years from Rule if implantable, 9/15
  • Direct part marking: 3 years from Rule, 9/16 if the device is:
    • Intended to be used more than once and intended to be sterilized before each use
    • Stand-alone software regulated as a medical device
Not Class III but implantable, life-supporting, and life-sustaining devices
  • UDI on labels: 2 years from Rule
  • GUDID Interface: 2 years from Rule
  • Direct part marking: 2 years from Rule if implantable
Class II
  • UDI on label and package, 3 years from Rule
  • GUDID Interface, 3 years from Rule
  • Direct part marking, 2 years from Rule if implantable, 5 years from Rule if the device is:
    • A device intended to be used more than once and intended to be sterilized before each use, or
    • A stand-alone software regulated as a medical device
Class I
  • UDI on labels, 5 years from Rule for class I medical devices and devices that have not been classified into Class I, Class II, or Class III
  • GUDID Interface, 5 years from Rule, data for Class I, devices and devices that have not been classified into Class I, Class II, or Class III.
  • Direct part marking, 7 years from Rule Class I, devices and devices that have not been classified into Class I, Class II, or Class III required to be labeled with a UDI permanent mark.