Quick Summary
Unique Device Identifier (UDI) compliance trips up many medical device manufacturers in two predictable places: the Direct Marking (DM) requirement and the meaning of a device's "label." This article explains why DM is in addition to the UDI on the label and package, how FDA's 2017 guidance defines "used more than once" and "reprocessed before each use," and why a label is a regulatory concept rather than a sticker on a box. Get these right and you avoid both over-marking and missed obligations.
One of the most misunderstood and misapplied requirements with respect to UDI is related to the Direct Marking (DM) requirement.
The primary (default) location for a device’s UDI is on the label of the device (and its packaging, if any), and in many situations, this adequately addresses the need to identify the device through distribution and use. However, some devices are separated from their labels (packages) – and used (and reused) many times, often over an extended period of time. The original use case for this additional requirement is reusable surgical instruments – devices that are removed from their packaging, used, and reprocessed/reused many times, and where the identification and traceability of a specific instrument would be very beneficial, especially, for example, in cases of transmittable diseases (e.g., Creutzfeldt–Jakob disease [CJD]). There are certainly many other devices (e.g., endoscopes, tracheostomy tubes) where this identification is also critical.
Direct Marking Unique Device Identifier Regulations
The first issue that must be understood is the DM requirement is in addition to having a UDI on the device’s label and package.
The U.S. FDA’s UDI regulation states:
801.45(a) A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
In November 2017, the U.S. FDA published additional guidance that explained, for U.S. UDI implementation, what “used more than once” and “reprocessed before each use” mean. Importantly, the guidance excluded single patient use devices from “used more than once” – and excluded those devices that are only cleaned between patient uses from “reprocessed before each use.” However, we have seen situations where the reprocessing guidelines distributed by the manufacturer have not been reviewed in many years – and are not current with respect to the FDA’s current thinking on device reprocessing. We encourage manufacturers to (re-)assess the reprocessing guidelines before deciding whether cleaning alone is sufficient reprocessing. The U.S. FDA has several guidance documents on this topic.
The Most Common Mistake
Teams frequently treat Direct Marking as a substitute for the label/package UDI rather than an addition to it. If a device must bear a UDI on its label, is intended to be used more than once, and is reprocessed before each use, it needs both the labeled UDI and a permanent UDI marked directly on the device. Skipping either side of that equation is a compliance gap.
When the Label Lives on the Device Itself
The other area where we see confusion is related to the device's label. In some situations, the device’s label is on the device itself. This may not always be obvious as many incorrectly believe that a label is a sticky piece of paper on the package of the device. In reality, label is a regulatory concept and refers to the location in which regulatory information (e.g., name of the device, name of manufacturer) exists. In some situations, this information is on the device itself, which means that the device’s UDI goes on the device at this level. Moreover, an additional or different UDI is not also required to be on the device since the label on the device serves both purposes. Therefore, when assessing the relevance of the DM requirement, it is critical to first evaluate whether the device’s label is (or should be) in the device itself. However, in these situations, it is also critical to understand that the label requirements take precedence; it is the label requirements (and deadlines) that must be met.
A Practical Way to Assess Direct Marking
- Is a UDI required on the label? If the device must bear a UDI on its label, you are inside the DM analysis.
- Is the label already on the device? If the regulatory information lives on the device itself, the label requirements (and deadlines) take precedence and a separate DM UDI is not additionally required.
- Is it used more than once? Single patient use devices are excluded from “used more than once.”
- Is it reprocessed before each use? Devices only cleaned between patient uses are excluded from “reprocessed before each use”—so revisit your current reprocessing instructions against FDA’s current thinking.
- If yes to both, a permanent UDI must be marked directly on the device in addition to the label/package UDI.
Because these determinations hinge on accurate, well-governed product and labeling records, manufacturers benefit from treating UDI as part of a broader data integrity and computer software assurance (CSA) discipline rather than a one-time labeling task. Keeping reprocessing instructions, label content, and submission data accurate and current is the difference between a defensible UDI program and a recurring audit finding.
In a related blog post, we look at the evolving global UDI landscape.
Learn more about USDM's UDI solutions for the medical device industry and how a Cloud Assurance approach keeps validated systems audit-ready as requirements evolve.
FAQ: UDI Direct Marking and Labeling Requirements
Is Direct Marking a replacement for the UDI on the label?
No. Under FDA regulation 801.45(a), Direct Marking is in addition to having a UDI on the device’s label and package. A qualifying reusable device needs both the labeled UDI and a permanent UDI marked directly on the device.
Which devices must bear a Direct Marking UDI?
A device that must bear a UDI on its label must also bear a permanent UDI on the device itself if it is intended to be used more than once and intended to be reprocessed before each use. Reusable surgical instruments are the original use case, but endoscopes, tracheostomy tubes, and similar reusable devices are commonly in scope.
What did the November 2017 FDA guidance clarify?
It explained what “used more than once” and “reprocessed before each use” mean for U.S. UDI implementation. The guidance excluded single patient use devices from “used more than once,” and excluded devices that are only cleaned between patient uses from “reprocessed before each use.”
What does “label” actually mean in the UDI context?
Label is a regulatory concept—it refers to where the regulatory information (such as the device name and manufacturer name) exists, not a sticker on the package. When that information is on the device itself, the device’s UDI goes on the device at that level, and a separate DM UDI is not additionally required because the label serves both purposes.
How should manufacturers reassess reprocessing guidelines?
Many manufacturers’ reprocessing instructions have not been reviewed in years and may not reflect FDA’s current thinking. Before concluding that cleaning alone is sufficient reprocessing, re-assess your guidelines against FDA’s available guidance documents on device reprocessing.
Get UDI Right the First Time
Whether you are scoping Direct Marking, reconciling label content, or modernizing how your validated labeling systems stay compliant, USDM can help. Contact us to talk through your UDI program, or explore our computer software assurance and Cloud Assurance capabilities.