FDA UDI regulations were released in the final UDI Rule on September 24, 2013 and captured in the Code of Federal Regulations (CFR) at 21 CFR 801 (Subpart B) UDI Labeling and 21 CFR 830 Unique Device Identification.
At a high level, US regulations establish the following requirements:
- Label: Apply UDI (Device ID + Production ID) on Device Product and Package labels. Present UDI in human-readable plain-text & Automatic ID and Data Capture (AIDC) technology (e.g., 1D/2D barcode, RFID)
- Direct Mark: Permanently mark UDI on the device if multiple-use (different patients) and reprocessed (high-level disinfection and/or sterilization)
- GUDID: Submit device UDI information to GUDID, include 57 attributes including DI. (NLM public portal is at Access GUDID)
- Documentation (QMS): Include UDI in Annual Reports, DHR, Complaints, MDR, Recalls, Service, Tracking, Post Market Surveillance. Comply with electronic records. Retain records 3 years after discontinuation
Labeler
The FDA created a term “Labeler” as the party responsible for UDI compliance.
Any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.
In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.
Issuing Agency
Each labeler is required to register with an FDA-accredited Issuing Agency to assign UDIs. FDA has approved GS1, HIBCC, and ICCBBA.
GUDID
FDA created the GUDID, Global Unique Device Identification Database, to store submitted product UDI information. Labelers can submit product information to the GUDID via manual entry using the FDA GUDID Web Interface or electronically using XML file uploads via the Electronic Submissions Gateway (ESG).
The Access GUDID database, hosted by the National Library of Medicine (NLM), was launched in 2015; it provides public access to FDA GUDID content and supports search, download, and web services.
By establishing final UDI Rule system for the adequate identification of medical devices through distribution and use, the UDI Rule will serve several important public health objectives:
Reduce Medical Errors: The presence of a UDI that is linked to device information in the GUDID will facilitate rapid and accurate identification of a device, thereby removing a cause of confusion that can lead to inappropriate use of a device. Using a device’s UDI, you will be able to use the GUDID to positively identify the device and obtain important descriptive information, preventing confusion with any similar device, which might lead to misuse of the device. Health care providers will no longer have to access multiple, inconsistent, and potentially incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information.
Simplify the Integration of Device Use Information into Data Systems: UDIs, particularly when provided through AIDC technology, will allow rapid and accurate data acquisition, recording, and retrieval. For example, the use of UDIs in computerized physician order entry systems will help ensure that the intended device will be used in the treatment of a patient rather than some similar device that may not fully meet the needs of the health care professional who ordered the use of the device.
Provide for More Rapid Identification of Medical Devices with Adverse Events: An essential prerequisite to resolving adverse events is the timely and precise identification of the particular device or devices that may have a connection with an adverse event. The inclusion of UDIs in adverse event reports would lead to greater accuracy in reporting by eliminating uncertainty concerning the identity of the device that is the subject of a report.
Provide for More Rapid Development of Solutions to Reported Problems: The rule requires the inclusion of UDIs in adverse event reports that are required. This will allow manufacturers and the FDA to more rapidly review, aggregate, and analyze related reports regarding a particular device, leading to more rapid isolation and identification of the underlying problems and the development of an appropriate solution to a particular concern.
Provide for More Rapid, More Efficient Resolution of Device Recalls: Delays in identifying recalled devices can result in the continued use of those device on patients and involves an increased risk for patient harm. A device labeled with a UDI can be identified rapidly and with great precision. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced or eliminated.
Better Focused and More Effective FDA Safety Communication: By citing UDIs, the FDA will be able to more precisely focus safety alerts, public health notifications, or other communications, eliminating confusion with similar devices and allowing more rapid, responsive action. Users of similar devices that are not the subject of the safety alert would be relieved of the uncertainty concerning whether they have been exposed to, or are affected by, a problem or risk.
Standard Format for Dates Provided on a Device Label: The rule will also better ensure dates on device labels are not confusing or misleading to users, thereby ensuring the safe use of devices, by requiring that dates on medical device labels conform to a standard format consistent with international standards and international practice year-month-day (e.g., 2013-09-30). This will ensure dates on medical device labels are unambiguous and clearly understood by device users.
In order to simplify UDI labeling and GUDID submissions for your medical devices, it is essential to have a thorough understanding of the entire process involving development, validation, design, and submission of requirements. It is crucial to stay up-to-date with UDI compliance standards to ensure smooth operations.
