Discover how to adapt international device labeling for FDA compliance. Learn best practices on language, UDI, symbols, and regulatory differences to ensure a smooth U.S. market entry while avoiding misbranding risks.
For medical device companies entering the U.S. market, one key challenge is aligning existing international labeling with U.S. FDA requirements. Devices that have been sold in Europe, Asia, or other regions often need adjustments to their labels and documentation to meet American regulations. Here are best practices to ensure a smooth transition from global labeling to FDA-compliant labeling:
Start by recognizing that while there are similarities in global device labeling principles, the U.S. has its own specific rules under 21 CFR 801 and related regulations. For instance, 21 CFR Part 801 is very prescriptive and covers all aspects of labeling from UDI requirements to the use of symbols and translations, whereas the EU’s requirements are laid out in the EU MDR’s Annex I (section on information supplied with the device). One key difference: the EU requires compliance with multiple national language requirements and the presence of a CE Mark and Notified Body number on the label (for CE-certified devices), while the U.S. FDA does not use CE marking and instead mandates things like the FDA UDI and the statement of identity in English. When adapting an EU label for the U.S., you will typically remove the CE Mark and NB number, as they are not relevant or required in the U.S. – in fact, keeping them might confuse users or imply compliance with standards that the FDA doesn’t regulate on labeling. Ensure you add any U.S.-specific identifiers, like the U.S. FDA Establishment Registration number if you choose (not required on label, usually on packaging if used) or other registration details as needed.
A major adjustment is language. The U.S. requires device labeling to be in English (for distribution in the U.S.), except in territories or locales where another language is predominant (e.g., Spanish in Puerto Rico). In contrast, the EU MDR requires providing labeling in the official languages of each EU member state where the product is sold – which can mean translating into 20+ languages. For U.S. entry, you can usually streamline to English-only labeling. If your global packaging currently carries multiple languages to serve various markets, you might consider creating a U.S.-specific version that has English only, to provide clarity and make room for any FDA-required details. Also, units of measurement should be considered: the U.S. traditionally uses some non-metric units (like inches, Fahrenheit) in clinical settings, but most device labels in the U.S. now use metric units (cm, Celsius) in accordance with international standards. FDA doesn’t force imperial units; metric is acceptable and often preferred for consistency. Just ensure whichever units you present are clear and standard (e.g., use “mm” not some local abbreviation).
Manufacturer vs. Importer: In Europe, if the manufacturer is outside the EU, the label must include the name and address of the Authorized Representative in Europe and the importer’s information, per MDR. In the U.S., FDA does not have an “authorized rep” concept exactly like Europe’s; instead, the label must have the manufacturer, packer, or distributor’s name and address (which could be an entity in or outside the U.S.). Many foreign manufacturers choose to list their U.S. distributor or subsidiary to satisfy this requirement and to give U.S. customers a domestic contact point, but it’s not strictly required to have a U.S. address on the label as long as the actual manufacturer’s address (including country) is listed. Best practice: If you’re a non-U.S. company, consider using a U.S. office or distributor address on the U.S. label with a qualifier (“Manufactured by XYZ Corp., Tokyo, Japan, Distributed by XYZ Inc., Los Angeles, CA”). This meets the requirement and is reassuring to users. But do note, you must register and list with FDA and have a U.S. Agent for FDA communications, but those details (registration number, agent) do not go on the label. So, align your label to list the responsible company name and address in a way that’s acceptable to FDA – often your existing label might already have the manufacturer address, just ensure it’s in English and includes a ZIP/postal code and country as needed.
If your device has been on markets like the EU, Switzerland, or others with their own UDI systems (the EU has a UDI requirement under MDR as well), you need to make sure the UDI on your label complies with the U.S. system. The good news is the U.S. UDI is based on global standards, so if you’ve implemented UDI using an issuing agency like GS1, the same barcode often can serve both markets. However, the databases differ: the U.S. uses GUDID, while the EU uses EUDAMED’s UDI database. You will need to obtain a UDI-DI specific to the U.S. GUDID (it might be the same DI code, but you must formally submit it to GUDID). Check that the human-readable format on the label meets FDA’s format rules (e.g., date format YYYY-MM-DD for any dates on the label per 21 CFR 801.18). If your international label includes a lot number and expiration date, for U.S. compliance make sure the expiration is printed in the ISO standard date format, as FDA requires that for devices manufactured after a certain date. Aligning UDI might be as simple as adding the HRI (Human Readable Interpretation) of the code if your EU label only had the barcode.
The EU MDR encourages use of harmonized symbols to convey info (like the CE mark, the Rx-only symbol, lot number symbol, etc.) and requires a symbols glossary if not obvious. The U.S. now (since 2016) allows the use of standalone symbols without adjacent text as long as they are from a recognized standard and the symbols glossary is provided (or symbols are explained in the IFU). If your international label already uses ISO standard symbols (e.g., a circle “do not use if package is damaged” icon, or the hourglass for expiry), you generally can keep those for the U.S. – they help avoid language issues and FDA is fine with them as long as they meet the rule in 21 CFR 801.15. One thing to adjust: The “Rx only” requirement in the U.S. for prescription devices. The EU doesn’t have an exact equivalent; EU devices often have a symbol of a circled “Rx” or just rely on being in professional use. For U.S., ensure the phrase “Rx only” or the official symbol is on your label if applicable. Conversely, remove any EU-only symbols that might confuse U.S. users (for example, the exclamation mark-in-triangle warning symbol is universal, but the Italian language requirement symbol “I” in a box is EU-specific, etc.). Always include the symbol legend in the packaging insert or IFU for U.S. users, unless the symbols are part of a standard recognized by FDA (check FDA’s list of recognized standards to be sure).
In some countries, labels carry specific registration numbers or codes (like a CFDA registration in China, or a TGA ARTG number in Australia). The U.S. generally does not require any such registration numbers on the label. Do not carry over foreign government registration numbers onto the U.S. label; they are not meaningful here and could confuse or mislead. One thing the U.S. does require for certain devices is the Indications for Use to be reflected at least in the IFU. Ensure the U.S. IFU or package insert clearly states the indications/intended use as given in your FDA clearance letter, which might differ slightly from what you printed for other markets. Also, radiation-emitting devices (like lasers) have additional U.S. labeling requirements per 21 CFR 1040 – like specific caution labels – which might differ from international IEC laser labels. So check if your device falls into a category with special labeling regs in the U.S. (electrical safety labels, radiation, MRI compatibility labeling per ASTM, etc.) and align accordingly.
Sometimes devices are sold in different configurations in the U.S. vs elsewhere (due to reimbursement or market practice). Ensure the labeling reflects any U.S.-specific configurations. For example, maybe in Europe you bundled accessories, but in the U.S. they must be sold separately – the labels and IFUs should not list the accessory if it’s not in the package. Adjust the content list or kit labeling to the U.S. offering. Another example: U.S. sterilization expiration dating may be handled differently; ensure any shelf-life printed is backed by data that FDA reviewed if they did, or remove it if not required.
It’s wise to implement a global labeling change control system where any change in one region triggers an evaluation in others. For instance, if you update a warning on the EU label due to a vigilance report, update the U.S. label likewise if applicable. Conversely, an FDA-driven change (like adding a UDI or a new contraindication from a 510(k) update) should be propagated to international labeling where needed. Harmonizing content as much as possible, while still meeting local requirements, is efficient. Maintain a “labeling requirements matrix” that highlights the differences between U.S., EU, Canada, etc. This way, you can double-check that each region’s version has everything it needs.
FDA has guidance documents and recognized standards for things like UDI, symbols, and electronic labeling (for certain devices). Leverage these resources. Also, if you’re unsure about a particular difference (for example, whether a certain phrase is acceptable), consider reaching out to the FDA’s Division of Industry and Consumer Education (DICE) or using the pre-submission process to ask labeling questions if it’s a major issue. Usually, though, straightforward adherence to 21 CFR 801 and copying any analogous info from your international labeling will suffice.
In summary, adapting global device labeling to U.S. requirements requires careful review of content, language, and regulatory details. Many fundamental requirements overlap – for instance, both US and EU demand the device name, manufacturer, lot/serial, and applicable warnings on the label. But the differences – like language, the presence of UDI vs CE mark, and specific statements – must be addressed to avoid misbranding in the U.S. By following the best practices above, a company can efficiently create U.S.-compliant labeling without reinventing the wheel, and ensure that when the device hits the American market, its labels and instructions satisfy FDA’s rules while still making sense to users who may be familiar with the product elsewhere.
