Greetings, MedTech enthusiasts! We are finally on the other side of developing and implementing our quality management systems. It has been quite a while, and indeed most of the journey in bringing a medical device to market. Now there are just a couple more steps to be taken before submitting your application to market your device to the US FDA.
This week’s post is dedicated to a fundamental aspect of medical device compliance: labeling. Labeling is more than just a regulatory hurdle; it’s a vital means of communication between manufacturers and users. Proper labeling is a crucial component of ensuring patient safety and effective product use. First, we will discuss the general labeling requirements addressed in 21 CFR part 801. Then, we will touch on unique device identification (UDI).
General Labeling Requirements
General labeling requirements for medical devices are found in part 801 of the code of federal regulations. The part itself is quite long but about half of it is specific to certain devices/types of devices. This post will not cover requirements for specific devices or types of devices. The first half of the part, however, details requirements applicable to all medical devices. For the most part, these requirements fall into one of two larger categories: content and format, and placement and visibility.
As far as content goes, the labeling must include directions for use, device identification, warnings and precautions, indications for use and contraindications, the manufacturer’s name and place of business, and if appropriate, an expiration date and/or maintenance or servicing instructions. Now, at this point, it is beneficial to distinguish between ‘label’ and ‘labeling’. The label is any written, printed or graphic matter affixed to the device itself or an immediate container (i.e. packaging), whereas labeling includes all labels as well as written, printed or graphic material accompanying the device. An easy way to understand the difference is thinking about a device user manual. The user manual is (generally) not affixed to the device or packaging but is included with it. Therefore, the user manual is labeling but not a label. Similar distinctions can be made with marketing material and advertisements.
The next question likely to be on everyone’s mind after reading the preceding paragraph is, what needs to be on a label on the device or packaging and what needs to be included in the labeling? The label(s) itself needs to include proper device identification (including common name and UDI, the trade or brand name may or may not also be included), the manufacturer’s information and any important warnings or precautions for device use. Labeling on the other hand, needs to collectively encompass all of the other previously stated requirements that are applicable to the device. In general, information that is required on the label cannot be moved onto the labeling (unless specific technical issues render it impossible to place on the label itself i.e., an implantable device being too small to bear all the required information), however, certain aspects of the labeling can be moved to the labels, if space and technology allow. An example of this would be how indications for use and directions for use are often included on the actual label of over-the-counter devices, in lieu of providing an additional user manual, but you cannot choose to not include the manufacturer’s information or device identification on the physical label just because you provide an instruction manual with the device that has that information.
Moving onto placement and visibility, there are two reasons these factors are important in medical device labeling. The first is so that the device may be adequately identified throughout its lifecycle, which facilitates vigilance reporting and event investigations. The second is risk mitigation and the safety of the user. The label placement is required to be in a prominent observable position during use or, in the case of over-the-counter devices, a place it is likely to be observed during review and purchase of the product. The FDA does have general size requirements for over-the-counter devices, such as requiring that one whole side of a rectangular box be dedicated to the labeling or about 40% (not including tops and bottoms) of other containers.
Another important consideration in placement is that all required statements need not all be on a single label, in fact, they should be prominently positioned to be easily seen when the information on the label is actually needed. For example, the label that bears the device identification may be in the front of the device, where it will be seen during use. However, an electrical hazard warning label for the same device might be on the back of the device, where the electrical enclosure is. The placement of the second label is based on the electrical hazard and therefore pertinent only to someone who would be opening the electrical enclosure and it is placed such that it is to be observed by someone performing this action and not necessarily by someone just operating the machine. In general, warning labels are placed near the where the hazard they are warning about are or where the user of the device is likely to be when the hazard presents itself, while identifying labels are placed in locations easily seen during use of the device.
Unique Device Identification (UDI)
Every medical device marketed on the US market must bear a UDI unless one of the exemptions listed in part 801 can be claimed for the device. A UDI is a two part number which provides information on what the device is, who markets it and information specific to that individual device. In order to obtain a UDI you must contact one of the UDI issuing agencies listed on the FDA’s website and request a UDI. The agency will issue the first part of the UDI, the device identifier. The device identifier is a number specific to the version or model of the device and the labeler of that device. The second part of the UDI the labeler assigns the device. This second part is called the production identifier and is generally either the date of manufacturer of the specific device (or lot or batch of devices), the lot or batch numbers themselves or, if the device has one, an expiration date.The organization can also choose to create its own numbering scheme for production identifiers if it finds it does not maintain adequate traceability with any of the above methods.
After you have been assigned your device identifier and created your chosen format for production identifiers, you must submit information on your organization and device to the Global Unique Device Identification Database (GUDID). As far as the organization goes, the FDA just needs the name of the organization and the name and contact information of an individual who is responsible for communicating with the FDA about the UDI’s. From the Device perspective, they will of course need your device identifier and the proposed format for the production identifier. They will also require general information about the device such as, trade name, model/version, size range and any device specific labeling required for the device by FDA. The full list of required information is in 830.310 (b) but you will likely not have more than what is listed here until after your premarket notification/application is accepted, if one is required, if one is not required (i.e. for most class I devices), you will just need the FDA’s listing number for the device in addition to the previous information.
Conclusion
Medical device labeling is honestly quite a massive topic to undertake. I hope this brief introduction was enough to give the readers a solid foundational understanding of the labeling requirements. Navigating the complexities of medical device labeling may seem daunting, but it's a vital part of the journey to market. The FDA has determined that a significant percentage (reaching 40% in some time frames) of adverse events were at least partially caused by inadequate labeling. This is causing labeling to be more closely examined during premarket applications and the FDA will want documented evidence (usually usability studies) that labeling whose purpose is to mitigate risk, actually mitigates that risk. With the right approach and a clear understanding of regulatory expectations, you can ensure your device is not only compliant but also ready to make a positive impact on patient lives.
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