Three important considerations to ensure compliance with the UDI mandate

Since September 24th, 2023, all newly labeled devices must comply with all the latest Unique Device Identification (UDI) requirements as set forth by the FDA, which includes guidance that legacy FDA identification numbers should not be used on any devices manufactured after this date.

Let’s take a look at what is required to ensure seamless compliance with the UDI mandate.

1. The UDI label must include all important pieces of information about the device. 

The Unique Device Identifier is intended to contain a variety of information, including device model, lot or batch number, serial number, expiration date, manufacture date, and other key data points. All of these bits of information must be included in the proper formatting.

Omron’s complete solutions for traceability take the comprehensive UDI requirements into account to ensure that all necessary elements are present in the label. For industry professionals seeking to learn all they can about UDI requirements, learn more about best practices and seamless compliance by reading our white paper, "Ready for the UDI Mandate Deadline?".

2. The label should contain the UDI in both human-readable and machine-readable formats.

The device labeler must provide the UDI in two forms on labels and packages: an easily readable plain text as well as a machine-readable form. Plain text allows providers, regulators and other stakeholders to enter UDI information into patient records more easily, whereas the machine-readable form allows for automatic identification and data capture (AIDC) technology.

The label’s machine-readable portion should be readily scannable by a barcode reader or other automated system, and the appropriate industry standards for data structure and formatting should be met. Comprehensive label verification solutions can ensure high-quality barcodes to maximize readability over the long term.

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It goes without saying that both the human readable and machine-readable UDIs should fully match, so checking this should be part of any verification process. Any mismatch could lead to the device being unfit for sale.

3. Labels and other markings should be capable of withstanding typical environmental pressures.

The label should be designed to withstand normal handling, storage, and shipping conditions, and should stay legible and intact throughout the product's lifecycle. This is especially important in situations where labels are likely to be exposed to heat or chemicals that could impact their readability.

Direct part marks, or DPMs, are an excellent option for medical devices like surgical instruments that must be frequently sterilized at high temperatures. They’re also great for devices where the UDI must fit within a tiny space (this is a common concern for surgical instruments as well).