25 Nov Deciphering the Unique Device Identifier (UDI) Code
Three letters have caused quite a stir in the medical device industry. U. D. I. What does it mean? How does a company comply with the new rule? Fortunately, Unique Device Identifiers are not as daunting as they first appear, and they also offer an excellent opportunity for the industry to establish better device traceability and accessibility. Below is a step by step guide for unlocking the secrets of the UDI.
The Basics: What is a UDI?
A UDI is a numeric or alphanumeric code that is assigned to a medical device. These codes are completely unique to the assigned device. The UDI consists of two parts:
- DI (Device Identifier) – a fixed section of the UDI that identifies the specific model of device and the labeler.
- PI (Production Identifier) – a variable section of the UDI that identifies the lot or batch number, serial number, expiration date, manufacture date. (1)
- The PI also includes a distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.(2)
The purpose of a UDI is to enable the FDA, industry, and device users to rapidly identify a device and its appropriate use. The UDI system aims to address several important public health objectives. These objectives include creating a central repository for medical device information, assisting with adverse event reporting, and improving the process for identifying a device which may lead to a reduction in medical errors. (2) (3)
A UDI can be issued by an FDA-accredited issuing agency. The list of agencies can be found here: UDI Issuing Agencies.
Timeline – When to Conform?
The FDA has issued compliance dates for Medical Device Companies. The dates are as follows
*ILL – implantable, life-supporting, and life-sustaining devices (4)
Figure 1: Timeline for UDI Compliance Dates
- 1 year after publication of the final rule, class III device labels and packages must bear a UDI and the data be submitted to the Global UDI Database (GUDID) (this includes class III life-supporting or life-sustaining devices).
- 2 years after publication of the final rule, the labels and packages of re-usable and sterilized implantable, life-supporting, and life-sustaining devices (class I, II, or unclassified) must bear a UDI and the data should be entered into the GUDID. If the device is intended to be re-used, then the UDI must be on the device itself as well.
- 3 years after publication of the final rule, class II device labels and packages must bear a UDI and the data be submitted to the GUDID. Class III intended to be used more than once and intended to be reprocessed should bear a permanent UDI on the device itself. Note: The FDA issued an extension for certain product codes for single use implants, see the notice
- 5 years after publication of the final rule, the labels and packages of Class I and devices not classified as I, II, or III must bear a UDI and the data should be entered in the GUDID. Class II intended to be used more than once and intended to be reprocessed should bear a permanent UDI on the device itself.
- 7 years after publication of the final rule, all devices (unclassified, ILL, and class I, II, and III) intended to be used more than once and intended to be reprocessed must bear a permanent UDI on the device itself, and all data should be entered into the GUDID.(4)
For devices that are intended to be used more than once and intended to be reprocessed, the permanent UDI requirement does not apply if:
- The marking would compromise the safety and effectiveness of the device.
- It is not technologically possible to mark the device.(5)
Automatic identification and data capture (AIDC)
All UDIs are required to be presented both in a format that is recognized by an AIDC system (such as a linear barcode or QR code), as well as a human readable format. Figure 2 below shows an example of a GS1-128 AIDC Code and readable format (left) and GS1 Data Matrix and readable format (right).
Figure 2: a GS1-128 AIDC Code and a readable format (left) and GS1 Data Matrix and readable format (right). (8)
The FDA does make exceptions to the UDI labeling requirement. Below is a list of some of the most important exceptions. A full list can be found in the FDA UDI Guidance.
- Finished Devices – Manufactured and labeled prior to the FDA compliance date.
- Class I devices that have been exempted from GMP requirements.
- Export only devices
- Investigational devices
- Custom devices(2)
The Global UDI Database (GUDID)
The GUDID is an FDA managed publically accessible database that serves as a catalog of all devices with a UDI. This database allows the FDA, the Medical Device industry, and Healthcare providers to easily access information regarding the device. All manufacturers with devices that require a UDI on the label, package, and/or device must enter information into the Global UDI database. (7)
Manufacturers must obtain a GUDID account in order to enter device information into the database. Manufacturers may do it themselves or they can designate a third party to submit the data on their behalf. (2)
Information to be entered into the GUDID:
- The Device Identifier (DI) portion of the UDI (Model number and labeler information). Note: The production identifier (PI) will be unique to each individual device (batch, lot, expiration date, etc) and is not required to be entered into the GUDID.
- When reporting a substitution of a new device identifier, the device identifier that was previously assigned to device must be referenced.
- If the device bears a permanent UDI on the device itself, there needs to be a statement that the permanent marking on the device is identical to the DI identified in the database.
- The proprietary, trade, or brand name of the device as it appears on the label of the device;
- Any version or model number or similar reference that appears on the label of the device;
- A statement that the device is sterile, if applicable.
- If the device is labeled as containing natural rubber latex that contacts humans, or is labeled as having packaging containing natural rubber latex that contacts humans, a statement to that effect;
- Whether a patient may be safely exposed to magnetic resonance imaging, nuclear magnetic resonance imaging, or magnetic resonance tomography while using the device, or while the device is implanted in the patient.
- If the device is available in more than one size, the size of the particular version or model, together with the unit of measure, as it appears on the label of the device;
- The type of PI that appears on the label of the device;
- The FDA premarket submission number of a cleared or approved device, or a statement that FDA has by regulation exempted the device from premarket notification;
- The FDA listing number assigned to the device;
- The Global Medical Device Nomenclature (GMDN) code
- The total number of individual devices contained in the device package. (2)(7)
Figure 3: GUDID Attributes and example of a UDI as shown on a Label (7)
Putting all the Puzzle Pieces Together
What Does this Mean for You?
The process of implementing the UDI rule is complex and time consuming. There are many different pieces to the puzzle that need to be addressed in order for your company to adequately comply with the FDA’s regulations. A good first step is to create a team within your company to work together to take on the process. Another good step is to read up on the FDA Guidance documents regarding the UDI and GUDID processes (Please refer to the references section). Take the process in a step-wise manner and be sure to evaluate how each step will affect the rest of the company’s processes. For example, The Code of Federal Regulations has been updated as a result of the UDI Rule, and therefore the quality management system for your company will need to be updated (BBA will be providing a discussion of this in an upcoming newsletter.) Boston Biomedical Associates is available to assist you throughout this process. Please contact us for more information.
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- GS1 US. U.S. FDA Unique Device Identification (UDI) Rule Frequently Asked Questions (FAQs). GS1 Healthcare US. [Online]March 11, 2014.http://www.gs1us.org/DesktopModules/Bring2mind/DMX/Download.aspx?Command=Core_Download&EntryId=865&PortalId=0&TabId=785.
- Center for Devices and Radiological Health FDA. Unique Device Identification System: Small Entity Compliance Guide SmallEntity Compliance Guide. Guidance for Industry and Food and Drug Administration Staff. [Online] FDA, August 13, 2014.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM409401.pdf.
- Food and Drug Administration. Unique Device Identification System. Federal Register. [Online] FDA, September 24, 2013.https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system.
- U.S. Food and Drug Administration. Compliance Dates for UDI Requirements. Medical Devices. [Online] September 30, 2014.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm.
- Reed Technology. Unique Device Identification UDI Requirements and Timelines . Medical Devices Group Youtube. [Online]Reed Technology, October 29, 2013. http://www.youtube.com/watch?v=osLT5sW4VnM.
- Rouse, Margaret. Automatic Identification and Data Capture (AIDC). Search ManufacturingERP. [Online] TechTarget, November2010. http://searchmanufacturingerp.techtarget.com/definition/Automatic-Identification-and-Data-Capture-AIDC.
- Center for Devices and Radiological Health. Global Unique Device Identification Database (GUDID). Guidance for Industry andFood and Drug Administration Staff. [Online] FDA, June 27, 2014.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf.
- Clive P Hohberger, PhD, AIM North America Healthcare Committee. Automatic Identification Technologies for UDI: Bar Code &RFID. UDI Conference 2014. Baltimore, MD : s.n., 2014.