Pure Global AI
Free FDA document translation

Free FDA document translation

Translate an FDA medical device PDF into a working local-language draft, or turn foreign-language supporting material into an English preview. The first five pages are returned with the PDF layout preserved.

First 5 pages free39 target languagesDirect PDF downloadNo account required

Translate an FDA document PDF

First 5 pages · no signup
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Temporary files are deleted after processing. Do not upload patient-identifiable or confidential information. Output is an unreviewed machine-translation draft.
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Two practical FDA translation directions

Global teams may need to understand an FDA document locally, while US submissions may include source material that requires an accurate English translation. The free preview supports either direction.

FDA letters, guidance excerpts, decision summaries, public submission material, and compliance correspondence.
Foreign certificates, test summaries, manufacturing documents, and supporting evidence requiring an English draft.
Device Master File excerpts and cross-border documents used by US and global regulatory teams.
A quick terminology and formatting test before commissioning a complete reviewed translation.
DJ Fang
DJ Fang
MedTech Regulatory Expert

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What to verify in an FDA document translation

An English-looking document is not necessarily an accurate English translation. Regulatory owners should compare the complete source and target files.

Check regulation, guidance, submission, product-code, establishment, and application references exactly.
Preserve names, addresses, dates, identifiers, model numbers, test values, signatures, and attachment references.
Confirm whether the specific submission or export use requires certification or a translator statement.
Do not treat a translated public FDA document as legal advice or as a substitute for the current official source.
Regulatory boundary

The translated PDF is not an FDA determination

This free tool creates an unreviewed translation draft. It does not establish FDA acceptance, interpret requirements for a specific device, or provide a certified English translation. Check current FDA instructions and use qualified review where required.

Medical device translation hub

Translate another regulatory document

Each page uses the same free translation engine, but gives you the review context for a different medical-device document and search task.

IFU translation

Translate medical device instructions for use while retaining the PDF layout.

Label translation

Translate medical device label copy, warnings, storage text, and packaging information.

Technical dossier translation

Translate a technical dossier, technical file, test report, or evidence excerpt.

Regulatory submission translation

Translate forms, submission narratives, declarations, and authority correspondence.

View all translation tools
About this tool

FDA document translation: what to know before relying on the draft

The translator returns an unreviewed machine-translation draft of the first five pages. Use it for scoping and internal review; confirm terminology, identifiers, warnings, and any certified-translation requirement before release or submission.

Can I translate an FDA PDF for free?
Yes. Upload a PDF, select one of 39 target languages, and download a translation of the first five pages without an account.
Can the tool translate foreign evidence into English for FDA?
It can create an English draft, but you must verify the complete translation and follow the applicable FDA instructions for accurate or certified English translations.
Does the tool interpret FDA requirements?
No. It translates document content. It does not determine the correct pathway, answer an FDA question, or replace current official guidance and regulatory judgment.