FDA Translation Requirements for Medical Devices: 510(k), PMA and Device Labelling

Key Takeaways

• The FDA requires that all labelling for medical devices sold in the United States be in English. Devices sold in Puerto Rico and other US territories where another language predominates may also require that language.
• Foreign-language documents submitted to the FDA as part of a 510(k) or PMA application must be accompanied by a certified English translation.
• Device labelling under 21 CFR Part 801 must include specific information in English — including intended use, directions for use, warnings, and manufacturer details — and must be accurate, legible, and not misleading.
• Instructions for Use (IFUs) and patient-facing materials for devices distributed in non-English-speaking markets require translation into the local language — this is a distributor or importer requirement in each target market, not an FDA requirement.
• ISO 17100-certified translation processes are the recognised standard for regulated medical content; human translation with expert review is required — machine translation does not meet the standard.

For medical device manufacturers seeking US market clearance or approval, translation requirements arise at two distinct points: during the regulatory submission process itself, and in the labelling and documentation required for commercial distribution. Understanding what the FDA requires — and where translation quality standards matter most — is essential for avoiding delays to 510(k) clearance or PMA approval.

FDA submission requirements: 510(k) and PMA

The FDA's Center for Devices and Radiological Health (CDRH) accepts submissions in English. Where a submission includes documents originally produced in another language — clinical data from foreign studies, technical documentation prepared in the manufacturer's home country, or correspondence from foreign regulatory authorities — those documents must be accompanied by a complete and accurate English translation.

The FDA does not specify a particular certification format for these translations, but the translation must be accurate and complete. Any error or omission in a translated clinical or technical document may result in a request for additional information (AI letter), extending the review timeline. For 510(k) submissions, where the standard review timeline is 90 days, a translation-related AI letter effectively adds months to the clearance process.

510(k) submissions — premarket notifications for Class II devices typically require translation of any foreign-language performance testing reports, predicate device documentation, or clinical evidence. Where a foreign equivalent device is cited as predicate, its technical documentation and any relevant regulatory clearance letters must be translated.

PMA applications — premarket approval for Class III devices involves significantly more documentation than a 510(k). Clinical trial data, manufacturing quality documentation, risk analysis files, and non-clinical test reports that originate in another language all require English translation before submission. Given the volume of documentation in a PMA, translation project management is a significant component of US market entry for foreign manufacturers.

De Novo requests — novel devices without a predicate that seek a new classification through the De Novo pathway require the same standard of translated documentation as a 510(k) for any foreign-language source materials.

Device labelling requirements under 21 CFR Part 801

US device labelling is governed by 21 CFR Part 801. The regulation requires that labelling for devices distributed in the United States be in English and meet specific content requirements depending on the device class and intended use.

Key labelling elements required in English include:

• Name and place of business of the manufacturer, packer, or distributor
• Statement of identity — the common or usual name of the device
• Net quantity of contents
• Intended use — what the device is for
• Directions for use — adequate directions that allow a layperson to use the device safely and for its intended purpose, unless the device is intended only for professional use
• Warnings, precautions and contraindications — where applicable
• Expiry or use-by dates — where applicable

For devices intended for professional use only (prescription devices under 21 CFR 801.109), directions for lay use are exempt, but all other labelling elements must still appear in English.

Bilingual labelling — the FDA permits additional languages on device labelling alongside the required English, provided the English and the additional language versions are consistent with each other. Where bilingual labelling is used, both versions are evaluated for accuracy and compliance.

IFU translation for US distribution

Instructions for Use (IFUs) for devices distributed in the United States must be in English. For devices distributed to Spanish-speaking populations — including devices sold in Puerto Rico — Spanish-language IFUs or bilingual IFUs are often appropriate and may be required by distributors or healthcare systems.

For devices distributed internationally as well as in the US, the IFU translation strategy must account for the labelling requirements of each market. EU MDR, for example, requires IFUs in all official languages of the EU member states where the device is placed on the market. Managing IFU translation across multiple regulatory jurisdictions requires a coordinated translation memory approach to ensure consistency across all language versions.

Clinical data translation for FDA submissions

Where clinical evidence supporting a 510(k) or PMA originates from studies conducted outside the United States, the FDA requires that study reports and associated documentation be submitted in English. The translation must accurately represent the source document — any inconsistency between the source and translated version may be identified during review.

The FDA's acceptance of foreign clinical data is governed by 21 CFR 814.15 (for PMAs) and the guidance on the use of data from studies conducted outside the United States. These frameworks do not specify a translation standard by name, but the expectation of accuracy and completeness is equivalent to the ISO 17100 standard for human translation with expert review.

Translation quality for FDA-related documents

FDA-related medical device translation — whether for submissions or for commercial labelling — requires the same standard of quality as translation for EU MDR compliance: human translation by a subject-matter expert, independent review by a second qualified linguist, and documented quality processes.

Machine translation, even with post-editing, does not produce the level of accuracy required for regulatory submissions or safety-critical labelling. A translation error in a 510(k) submission delays clearance. A translation error in device labelling creates a compliance and patient safety risk.

Global LTS provides medical device translation services for FDA submissions and US device labelling under ISO 17100-certified workflows. Contact us to discuss your FDA translation requirements.

For related reading, see our guides on medical device labelling translation and IVDR translation requirements.