- What the FDA requires in terms of translation
- What the FCC requires in terms of translation
- Document types most commonly involved in these processes
- What quality level is appropriate for these processes
- How M21Global supports FDA and FCC certification processes
- Related Services
- Frequently Asked Questions
Exporting products to the United States means dealing with two of the most demanding regulatory bodies in the world: the FDA (Food and Drug Administration) and the FCC (Federal Communications Commission). Both require that foreign-language documents submitted as part of a certification or approval process are accompanied by a complete English translation. An inadequate translation does not just cause delays. It can lead to outright rejection.
What the FDA requires in terms of translation
The FDA's position is straightforward: any document submitted in a language other than English must include a complete English translation and a signed accuracy statement from the translator. This applies to medical device registration dossiers (510(k), De Novo, PMA), food and supplement labelling, drug package inserts and instructions for use, and clinical study reports.
The accuracy statement is not a formality. The translator or translation company formally affirms that the English content is a faithful and complete representation of the original. If the FDA identifies discrepancies, the approval process is suspended. For health-related products, translation errors carry direct regulatory consequences.
Terminology is a critical variable. Terms such as "sterile", "single-use", or "contraindication" have specific legal meanings within US regulatory frameworks. A translation that substitutes approximate equivalents for established regulatory terms is likely to trigger requests for clarification or result in dossier rejection.
What the FCC requires in terms of translation
The FCC regulates electronic equipment, radio devices, and communications technology. To obtain FCC certification for a product, manufacturers must submit technical documentation that may include user manuals, laboratory test reports, circuit diagrams, and declarations of conformity.
The core FCC requirement is that supporting documentation be in English or accompanied by an English translation. User manuals intended for the US market must be entirely in English. Test reports issued by accredited laboratories, often in German, Japanese, Korean, or Chinese depending on the manufacturer's country of origin, must be translated in full.
Unlike the FDA, the FCC does not prescribe a specific format for the translator's statement. However, technical accuracy is scrutinised just as closely, both by the accredited test laboratory and by the FCC authorised agent. An error in the description of emission specifications or radiation exposure limits can compromise the entire certification.
Document types most commonly involved in these processes
Documents submitted to the FDA and FCC share one characteristic: they are highly technical and typically produced by engineers or scientists, not communications professionals. The source text is already dense and specialised, and the translation must preserve that level of precision without introducing ambiguity.
For the FDA, the most common document types include:
- 510(k) and PMA registration dossiers (medical devices)
- Instructions for Use (IFU) and package inserts
- Biocompatibility and sterilisation study reports
- Quality management system documentation (ISO 13485)
- Food and supplement product labelling
For the FCC, the most common document types include:
- Emission test reports (EMC/EMI)
- User manuals and installation guides
- Block diagrams and electrical schematics
- Declarations of conformity and authorised agent letters
- Component data sheets
What quality level is appropriate for these processes
FDA and FCC submissions leave no room for error. The appropriate quality level is one that includes independent review, controlled terminology, and a documented, traceable process. Machine translation without thorough human review is not a viable option for regulatory dossiers. Neither is single-linguist translation without independent verification.
The right approach for business translation in a regulatory context involves, at a minimum, a translator specialised in the relevant technical or medical field, independent review by a second expert, and terminological quality control. This is precisely what M21Global's Estratégica service tier delivers: three linguists in sequence (translator, reviewer, and QA reviewer), an ISO 17100-audited workflow, and translation memories that ensure terminological consistency across the entire dossier.
The cost of a translation error in a regulatory submission is incomparably higher than the cost of doing the work correctly at the outset. Companies that have managed registration dossiers for other regulated markets understand this well, and the same logic applies when internationalising into new markets.
How M21Global supports FDA and FCC certification processes
M21Global has over 20 years of experience in technical and regulatory translation, with ISO 17100:2015 certification awarded by Bureau Veritas. The company works with European and Lusophone manufacturers exporting to the United States, covering language pairs including Portuguese-English, German-English, French-English, and Spanish-English.
The workflow includes translators with specific training in medical regulation (FDA, MDR, ISO 13485) and in electronics and telecommunications (FCC, ETSI, CE marking), project-specific terminology glossaries, and accuracy statements formatted to meet FDA requirements. M21Global also issues certified accuracy statements where the regulatory body requires them.
If your company is preparing an FDA or FCC submission and needs technical documentation translated with precision and full traceability, contact M21Global for a quote. Response time is within three business hours on working days.
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Frequently Asked Questions
Does the FDA require a sworn or notarised translator for document submissions?
No. The FDA requires a signed accuracy statement from the translator or translation company confirming that the translation is faithful to the original. A sworn or notarised translator in the legal sense is not required, but the person or company signing the statement bears formal responsibility for the accuracy of the content.
Do test reports issued by European laboratories need to be translated for FCC submissions?
Yes. If a test report is in a language other than English, it must be accompanied by a full English translation to be accepted as part of the FCC certification process.
Which languages are most common in FDA dossiers originating from Europe?
Portuguese, German, French, Spanish, and Italian are the most frequent, depending on the country of manufacture. All require complete translation into English, including technical, quality, and labelling documentation.
Is machine translation with human post-editing acceptable for FDA submissions?
It is not recommended for regulatory dossiers. The FDA examines accuracy and terminological consistency. Errors or inconsistencies can result in requests for clarification or rejection of the submission. The appropriate process involves specialist translation, independent review, and terminological quality control.
How long does it take to translate a 510(k) dossier into English?
This depends on the volume and complexity of the dossier. A 510(k) can range from 50 to several hundred pages of technical documentation. The timeline should be agreed with the translation provider at the planning stage to avoid compromising the regulatory submission schedule.
