As per the Food and Drug Administration (FDA) regulation, all Class I, II and III Medical Devices distributed through the United States and their territories, should carry by now a unique device identifier, or UDI. The FDA requested to commence with the compliance for this regulation on September 24, 2014 for Class III Medical devices and shall continue until September 24, 2020 for Class I Medical Devices.
“FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device post market surveillance, and facilitate medical device innovation.”(¹)
UDI Label and Marking Requirements (¹)
Every UDI must be presented in two forms:
- Easily readable plain-text, and
- Automatic identification and data capture (AIDC) technology. If the AIDC technology is not evident upon visual examination of the label or package, the label or package must disclose the presence of the AIDC technology.
Under the UDI Rule, the FDA defines Automatic Identification and Data Collection (AIDC) as: “Any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. 21 CFR 801.3.” (²)
If your device label includes a printed expiration date, date of manufacture, or any other date that you intend to be brought to the attention of the user, the dates must be presented in a specified format that is consistent with international standards and international practice. This format is: the year, using four digits: followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.
If your device is intended to be used more than once and intended to be reprocessed before each use, your device must have the UDI permanently marked on the device itself. This permanent UDI may be identical to the UDI that appears on the device label, or it may be a different UDI to distinguish the device itself from its packaging. The permanent UDI must be in either or both
- easily readable plain-text and
- AIDC form or alternative technology that will provide the UDI of the device on demand.
The permanent UDI requirement does not apply if your device that is intended to be used more than once and intended to be reprocessed before each use meets any of the following criteria:
- Any type of direct marking would interfere with the safety and effectiveness of the device;
- It is not technologically feasible to directly mark the device;
- The device is cleared/approved as a single use device; or
- The device already has a permanent UDI directly marked on the device. If you decide to make use of one of these exceptions, the basis of your decision must be documented in the design history file required by 21 CFR 820.30(j).
MultiSystems provide Automatic Identification and Data Collection Solutions that helps medical devices manufactures be in compliance with these UDI regulations.
Our solutions range go from the printing and direct marking devices, bar code and direct park marking readers, software, high quality thermal ribbons and labels that can easily:
- Endure the entire product life
- Maintain brand uniformity
- Resist sterilization and cleaning products
- Comply with UL Standards
MultiSystems provides all the programming and implementation services, report generation and tailored software solutions to address your manufacturing operation’s needs.
(¹) From the United States Food and Drugs Administration website
(²) (³) Extract from “Unique Device Identification System: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff”, August 13, 2014