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U.S. Food and Drug Administration (FDA): Translation Requirements for Documents in Another Language
Yes: FDA accepts certified translations from professional services such as eVerbary.
Who may translate: Not restricted; petitions name the translator
- $24.95 per page
- Usually 24 h for 1–3 pages
- Signed certificate of accuracy, PDF
- See the price before you pay
How we know · policy checked on October 21, 2026
FDA regulations ask for an accurate and complete English translation of every part of an IND, NDA or new animal drug application that is not in English, together with a copy of any original literature translated; device 510(k)s are refused if supporting content such as test reports is not in English.
The rules do not say who translates, and for petitions and comments FDA asks for the translator's name, address and qualifications, so a certified translation from a professional service such as eVerbary meets them. eVerbary translates the documents; we do not prepare or submit the application.
FDA at a glance
Does it accept eVerbary? Yes
The IND and NDA rules ask for "an accurate and complete English translation" of each part not in English (21 CFR 312.23(c), 21 CFR 314.50(g)), and 21 CFR 10.20 asks for a verified translation with the translator's name, address and qualifications (21 CFR 10.20: submission of documents to Dockets Management), so a certified translation from a professional service such as eVerbary meets them. Policy checked on October 21, 2026.
- Translation
- Accurate and complete English translation
- Who may translate
- Not restricted; petitions name the translator
- Original or copy
- Copy of original literature with translation
- Price
- $24.95 per pageUp to 250 words, certification included
- Delivery
- 24 hoursStandard for one to three pages
- Certificate
- SignedCertificate of translation accuracy, PDF
Checked on October 21, 2026. Sources are listed at the end of this page. Policies change: confirm on FDA's own page before you submit.
Worth knowing about FDA
Accurate and complete
The drug rules' standard; no restriction on the translator.
Original literature too
A copy of each translated publication goes with the translation.
Translator named
Petitions and comments: name, address and qualifications.
FDA requirements in detail
Translation
Drugs and biologics under an IND, and NDAs: an accurate and complete English translation of each part not in English (IND, NDA). New animal drug applications: the same, appended to the part (21 CFR 514.1: new animal drug applications).
Who may translate
Not restricted for applications.
For submissions to Dockets Management (petitions, comments, objections), the translation must be verified complete and accurate and give the name, address and a brief statement of the qualifications of the translator (21 CFR 10.20: submission of documents to Dockets Management).
Original or copy
A copy of each original literature publication that was translated goes with the translation (21 CFR 312.23: IND content and format, 21 CFR 314.50: content and format of an NDA, 21 CFR 10.20: submission of documents to Dockets Management).
Medical devices (510(k))
FDA's refuse-to-accept checklist requires that all content supporting the submission be in English, including translations of test reports and literature articles (RTA guidance).
Tobacco products
FDA may refuse to accept a premarket tobacco application that is not in English or lacks complete English translations (21 CFR 1105.10: refusal to accept tobacco submissions).
Program by program
For drugs the wording is identical in the IND and NDA rules: the sponsor or applicant submits an accurate and complete English translation of each part that is not in English, and a copy of each original literature publication it translated (21 CFR 312.23: IND content and format, 21 CFR 314.50: content and format of an NDA).
Animal drug applications follow the same pattern, with the translation appended to the foreign language part (21 CFR 514.1: new animal drug applications).
For devices, the regulations we read (510(k), PMA, IDE) contain no translation clause; the requirement comes from FDA's Refuse to Accept Policy for 510(k)s, whose first administrative checklist item is that all supporting content be in English, translations of test reports and literature articles included (FDA guidance: Refuse to Accept Policy for 510(k)s).
If FDA refuses to accept a 510(k), the review clock does not start until the submission is accepted.
Petitions and comments: the translator is named
21 CFR 10.20 governs what goes to FDA's Dockets Management Staff: citizen petitions, comments, objections and similar submissions.
There a foreign language part must come with an English translation verified to be complete and accurate, together with the translator's name, address and a short statement of qualifications, and a copy of the original publication (21 CFR 10.20: submission of documents to Dockets Management).
That is the strictest FDA wording and it still does not restrict who translates.
Our certificate of translation accuracy states that the translation is complete and accurate and gives our contact details; if you file under 10.20, ask for a free quote, write in the notes that the translation is for an FDA docket submission, and we confirm before you pay what the certificate will state.
Need a certified translation for FDA?
$24.95 per page of up to 250 words, certification included, usually within 24 hours for one to three pages. See the price before you pay.
Documents people usually translate
- Clinical study reports and investigator documents
- Laboratory and bench test reports
- Published literature articles cited in the submission
- Certificates of analysis and manufacturing records
- Foreign regulatory approvals and correspondence
What an eVerbary translation includes
- A complete English translation of every page, stamps, seals and handwritten notes included, laid out like the original so each line can be matched.
- A signed certificate of translation accuracy on letterhead, with our contact details, delivered as a PDF you can upload or print.
- $24.95 per page of up to 250 words, certification included; 24 hours for one to three pages as standard. Regular clients who need it can get delivery in as little as 30 minutes, on request.
- Notarization added at checkout ($34.90 per order) when the office asks for a notarized translation.
Submitting the translation to FDA
The sponsor or applicant includes the translation in the submission, next to the original material it translates, in the electronic format FDA requires for that program.
For a petition or comment to Dockets Management, the translation, the translator's details and a copy of the original publication are filed together (21 CFR 10.20: submission of documents to Dockets Management).
What we do not do
eVerbary translates documents; it is not a government agency or a filing service. We do not complete or file applications, and we do not issue or certify the original document.
For FDA that means we translate the documents; we do not prepare INDs, NDAs or 510(k)s, write summaries for them, or submit them through FDA's gateways.
How to order
- Scan or photograph every page of the document, front and back, including any stamps on the reverse.
- Upload it, choose the language and "certified", and see the price before paying.
- Receive the PDF, usually within 24 hours for one to three pages, and submit it with the copy of the original wherever the office asks for it.
Frequently asked questions
Does FDA require a certified translation?
The IND and NDA rules ask for an accurate and complete English translation (21 CFR 312.23: IND content and format); they do not use the word "certified" or say who translates. For petitions and comments FDA asks for the translator's name, address and qualifications (21 CFR 10.20: submission of documents to Dockets Management).
Do I have to include the original article with the translation?
Yes, for literature: a copy of each original publication that was translated (21 CFR 314.50: content and format of an NDA).
Does a 510(k) need translated test reports?
Yes. FDA's acceptance checklist requires all supporting content in English, including translations of test reports and literature (FDA guidance: Refuse to Accept Policy for 510(k)s).
Can eVerbary translate a long clinical or test report?
Yes, at the same price per page of up to 250 words, certification included; for long documents, ask for a free quote and we confirm the price and delivery time before you pay.
Sources
U.S. Food and Drug Administration (FDA)'s own pages, read on October 21, 2026.
Translating documents for FDA?
Upload a scan of your document and see the price and delivery time before you pay.