The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the unique device identification system.
In particular, the document is dedicated to the form and content of the Unique Device Identifier (UDI). The present document constitutes a final version of the draft guidance issued by the FDA earlier in July 2016. Due to the legal nature of the guidance, it does not introduce new rules and requirements but provides additional recommendations and clarifications on the matter to be considered by the medical device manufacturers and other parties involved. The Agency states that an alternative approach could be applied, provided such an approach complies with the relevant regulatory requirements and has been approved by the Agency in advance.
The regulatory matters covered by the guidance mostly fall within the scope of responsibility of the Center for Devices and Radiological Health (CDRH). However, certain aspects could be addressed to the Center for Biologics Evaluation and Research (CBER).
The present FDA guidance provides additional clarifications with regard to labeling requirements related to the unique device identifiers. In particular, the document describes how the provisions of 21 CFR 801.40 should be interpreted by the parties responsible for issuing UDIs and placing them on devices and packaging. The scope of the document covers the regulatory requirements related to the form and content of unique device identifiers in order for them to be compliant with the Unique Device Identification System Final Rule 78 FR 58786 (the UDI Rule).
First, the document provides the definitions of the most important terms and concepts used in the guidance and related to the topic. For instance, according to the applicable regulations 21 CFR 801.3 and 21 CFR 830.3, respectively, the terms below should have the following meaning:
- Labeler stands for (1) any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any intended subsequent replacement or modification of the label; and (2) any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.
- Issuing agency is an organization accredited by FDA to operate a system for the issuance of unique device identifiers.
In accordance with the UDI Rule, the label and package of any and all medical devices allowed to be marketed and used should contain a UDI compliant with the applicable regulatory requirements. However, in certain cases, an exemption could be applied. Additionally, the authority emphasizes that multiple-use medical devices that should be reprocessed before use should also have the UDI placed directly on the device. The scope of UDI requirements also covers stand-alone software, provided such software meets the definition of a medical device.
As stated in the guidance, the main purpose of the UDI regulations is to establish a harmonized approach to the identification system. According to the applicable regulation, the unique device identification system makes it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. The labelers should use the systems operated by the FDA-accredited issuing agencies to assign unique device identifiers to be placed on devices and their packaging.
The identifier itself should contain the information provided in two formats:
- Easily readable plain-text; and
- Automatic identification and data capture (AIDC) technology.
If the identifier is placed on a medical device itself, the information could be provided in either format or in both simultaneously.
The document describes in detail the aforementioned forms of unique device identifiers, provides additional clarifications regarding the information they should contain, and also highlights the main aspects to be considered, including the data format. The authority explicitly mentions that the scope of the document does not cover matters related to universal product codes (UPSs). Under the current regulatory requirements, a UPC could be used instead of the UDI for low-risk Class I medical devices. At the same time, the responsible party is allowed to decide to use a UDI instead.
Unique Device Identifiers in Detail
According to the definition provided in regulation 21 CFR 801.3, “unique device identifier” stands for an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 21 CFR 830.20. Under the general rule, a unique device identifier contains the following elements:
- A device identifier (DI), which is intended to identify the particular model of the device and responsible party; and
- A production identifier (PI), which is a variable element used to identify the batch, serial number, expiration date, or other details that are subject to changes.
According to the applicable regulations, a UDI should be issued under a special system operated by an FDA-accredited issuing agency. It should also comply with the applicable international standards, such as ISO/IEC 15459-2: Information technology – Unique identifiers—Part 2: Registration procedures; or ISO/IEC 15459-4: Information technology – Unique identifiers—Part 4: Individual items. The authority also mentions that all the elements (characters and numbers) the unique device identifier contains should comply with the applicable international standard in the field of information interchange. In order to ensure the effectiveness of the overall approach, systems operated by an FDA-accredited issuing agency should comply with the regulatory requirements for unique device identifiers set forth by 21 CFR Part 801.
As mentioned, the unique device identifier placed on the labeling or packaging of a medical device should contain information presented in both easily readable plain-text and AIDC technology forms. The first form is intended to assist healthcare professionals and patients in obtaining information about the medical device without additional equipment. This approach could also be applied in case the AIDC technology form is for some reason unavailable.
According to the guidance, the easily readable plain-text form (human readable interpretation or HRI) should contain the DI and PI (if applicable). In case both elements are present, the data delimiters should be used to facilitate the use of information. The current regulation provides certain flexibility with regard to the way the information in HRI form could be presented: it could be one or several lines of the text placed above or below the information provided in the AIDC technology form.
In summary, the present FDA guidance dedicated to the regulatory requirements in the sphere of unique device identification highlights the most important aspects to be considered, including the forms the information should be provided. The document describes in detail each form to be used to provide information about the medical device and its manufacturer in order to assist responsible parties in ensuring compliance with the applicable regulations.
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