Ensure FDA compliance by including all required labeling elements: manufacturer info, device name, intended use, warnings, UDI, lot/serial numbers, legibility, and truthful claims. Proper labeling prevents misbranding and promotes safe device use.
To comply with FDA labeling regulations, every medical device label must include certain critical information in a clear, conspicuous manner. These elements are mandated by 21 CFR Part 801 and Section 502 of the FD&C Act to ensure users can identify the device and understand its proper use. Key requirements include:
The label must display the name and place of business of the manufacturer, packer, or distributor, including at least the city, state, and zip code. For example, a company might label “Manufactured by ABC Medical, Inc., New York, NY 10001.” If the firm named is not the actual manufacturer (e.g. it’s the distributor), the label should clarify this with a phrase like “Manufactured for…” or “Distributed by…”. This requirement ensures accountability – regulators and customers can trace who is responsible for the product.
The device’s common or usual name (or its established name, if it has one) should appear prominently. In fact, if a trade name or brand is used, the common name must be printed in lettering at least half the size of the brand name on the label. The label or labeling should also identify the device’s intended purpose or use, especially if it’s not obvious from the name or design. This helps prevent misuse. For many devices, the indication for use is described in the instructions, but the outer label should not be misleading about what the product is. Any representation on the main label that is false or implies unapproved uses can be considered misbranding.
If applicable, the packaging must state the quantity of contents (e.g. number of units, volume, etc.) in terms of weight, measure, or numerical count. This lets purchasers know how much product is in the package. There are allowances for reasonable variations and exemptions for very small packages, but generally the amount can’t be omitted.
Directions for use are crucial for over-the-counter devices. The label or accompanying labeling should provide sufficient instructions so that a typical person can safely use the device for its intended purpose. This includes information like the device’s intended purposes and conditions, how and when to use it, the duration or frequency of use, and any necessary preparation before use. If the device is prescription-only, it is exempt from having “adequate directions for use” for a layperson provided it meets the FDA’s requirements for professional labeling. In such cases, the device labeling must include the federal caution statement – now usually abbreviated as “Rx Only” – indicating it is to be used only by or on the order of a licensed practitioner. Including the “Rx Only” legend (as per Section 801.109) fulfills the requirement in lieu of lay instructions. Failure to include adequate directions (for OTC devices) or the proper Rx designation (for prescription devices) can lead to a misbranding charge.
Any relevant warnings, precautions, or hazard statements needed to ensure safe use of the device must be clearly stated in the labeling. For example, if a product should not be used under certain conditions or by certain patients (children, pregnant women, etc.), or if there are hazards associated with misuse, those warnings should appear either on the label or in the accompanying instructions for use. FDA expects that “adequate warnings against use in those conditions where its use may be dangerous to health” are provided whenever necessary to protect users. Missing necessary warnings is a frequent cause of devices being deemed misbranded.
Under FDA’s UDI rule, most devices must bear a Unique Device Identifier code on their labels and packages. The UDI is typically presented in both human-readable text and machine-readable format (such as a barcode or QR code). It includes a Device Identifier (DI) – a fixed portion identifying the device’s manufacturer and model – and possibly a Production Identifier (PI), which is variable information like the specific lot or serial number, expiration date, or manufacturing date. For example, a device’s UDI might encode its model XYZ and that it was from lot 1234 expiring 01/2026. (Devices intended for multiple uses and reprocessed between uses must also have the UDI permanently marked on the device itself.) UDIs improve traceability and patient safety by allowing devices to be identified in databases and adverse event reports.
Even apart from the UDI system, device labels often include a lot number, batch code, or serial number for quality control and traceability. In fact, the inclusion of a lot/serial is a required element of labeling for many products, especially implantable or life-supporting devices, to facilitate tracking in the event of recalls. Under the UDI framework, lot or serial is captured as part of the UDI’s Production Identifier, so it effectively becomes a required labeling element through the UDI mandate.
All required label information must be prominently placed and legible under usual conditions of purchase and use. FDA regulation 21 CFR 801.15 outlines that required text should not be obscured by decorative packaging, must contrast with the background, and use a sufficiently large font. If the package is large enough, key information should appear on multiple sides, so it’s easily seen. In the United States, English is the required language for labeling (except in territories like Puerto Rico where Spanish or another predominant language may be used). If any labeling is presented in a foreign language alongside English, then all required information must also appear in that foreign language. This ensures that bilingual packaging isn’t misleading by having, say, marketing claims in one language that are not accompanied by the necessary warnings in that language.
As a general overarching rule, nothing on the label or labeling can be false or misleading. Claims about the device’s uses or performance must be truthful and supported by evidence. Comparative claims (e.g. “best in class” or “more effective than X”) are very risky unless backed by data, as unsubstantiated superiority claims can be deemed misleading[23]. Labeling must also avoid implying uses or effectiveness that have not been cleared or approved by the FDA – doing so can not only misbrand the product but also create a new “intended use” that the company has not obtained approval for (an off-label use issue).
By including all these essential elements, manufacturers help ensure their device is not misbranded and is ready for the U.S. market. It’s good practice to use a checklist during label design and review – for instance, does the label have the company name/address, the correct device name and intended use, all needed warnings, and the UDI barcode? Only once all required details are present and accurate can a device label be considered compliant. In the next section, we’ll explore one of these elements in greater depth – the “adequate directions for use” and accompanying warnings – since improper directions or missing precautions are common pitfalls in device labeling.
