General Context

  1. UDI is a Unique Device Identifier in the form of a unique number or alphanumeric code. It consists of plain text and AIDC (only readable via machine)
  2. Issued by an FDA-accredited issuing agency. UDI is granted for 3 years and can be renewed upon submission and FDA approval of a renewal application.
  3. UDI should contain:
    1. Device Identifier (DI) – Model and the labeler of the device. DI is mandatory so all UDIs must contain DI.
    2. Production Identifier (PI) – Portion of the UDI should identify one or more of the following attributes when the UDI is placed on the label of the device (conditional):
      1. Lot or batch number
      2. Serial number
      3. Expiration date
      4. Manufacturing date
      5. Distinct Identification Code (For Human Cell and Tissue Product)
  4. Placed at the bottom right of the device label.
  5. The Global Unique Device Identification Database (GUDID) ONLY stores DI and not PI. However, there are PI flags to indicate which PI attributes are on the device label.

CompuHyper GlobalMed

Steps to Establish UDI

  1. Hire an accredited Issuing Agency that develops the unique labeler code for use in UDIs.
  2. Place the UDI on the label and package and for some devices, on the device itself with Plain Text and Machine Readable AIDC.
  3. Enter the data in the UDI Database (GUDID).

Important Dates

Due Date Device Class
September 24, 2014 Class III, Class III stand alone software, Devices licensed under the PHS Act
September 24, 2015 Implantable, life-supporting and life sustaining devices including stand alone software
September 24, 2016 All Class II devices, direct marking for Class III devices and devices licensed under the PHS Act for certain intended uses
September 24, 2018 Class I devices, devices not classified as Class I, II or III, direct marking of class II devices for certain intended uses
September 24, 2010 Direct Marking of Class I devices, devices not classified into Class I, II or III for certain intended uses

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.