FDA 510(k) Translation | Angel Translation

Prepare English supporting documents for a 510(k): source traceability, terminology, attachment checks and submission-specific translation questions.

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Key points

Where the translation requirement comes from
Consistency is what gets noticed
Traceability
Check the eSTAR package, not just the prose

Who this is forRegulatory affairs teams preparing US submissions from non-English source documentation.

Where the translation requirement comes from

For a 510(k), identify the supporting documents that must be presented in English and retain their source versions. Your regulatory owner should confirm which records, extracts and attachments belong in this submission; do not translate an entire internal record set simply because it exists.

FDA’s current eSTAR instructions govern applicable electronic submissions. Confirm the current template, submission center and exemptions. A translation provider prepares the agreed language deliverables; the applicant owns submission content and filing.

Consistency is what gets noticed

A reviewer reads a submission as a set. When the device is described one way in the indications, another in the labelling and a third in the test reports, the discrepancy becomes a question — and questions consume review cycles.

Most avoidable friction we see comes from documents translated at different times by different hands, with no shared terminology. The fix is unglamorous: lock the terms first, against your existing approved labelling.

Traceability

A quality system expects a documented process with accountable steps. Text of unclear provenance — including unreviewed machine output — is harder to defend if the process is examined, regardless of whether the text happens to be correct.

Regulatory content therefore runs through domain expert review and a QA audit, and the process is documented.

Check the eSTAR package, not just the prose

FDA explains that a properly prepared eSTAR is generally subject to technical screening rather than the traditional Refuse to Accept process, with accuracy checks and possible holds. Do not describe every 510(k) as following the same RTA checklist.

Check that translated attachments match the cited names, page references and source revisions. Do not describe a completed translation as FDA approval or promise that it will prevent questions or a technical-screening hold.

Submission handoffA language check supports the applicant’s submission review.

Record	Check
Source and English files	Matching document IDs, revisions and complete agreed scope.
Product terminology	Device names, indications, units and references agree across attachments.
Applicant review	Current eSTAR instructions and unresolved issues checked by the regulatory owner.

Questions

Does FDA require a certified translation?

Requirements vary by submission type and are set by FDA, not by your language vendor. Confirm what your specific pathway requires with your regulatory consultant, and tell us the answer so the deliverable matches it.

Can we translate only part of a document?

Only when your regulatory owner confirms that the extract is appropriate for the submission. Identify omitted material and retain traceability to the full source; terminology consistency alone does not establish that a partial translation is acceptable.

Who reviews life science submissions?

Reviewers with relevant biomedical or clinical background, not general linguists. Judging whether a clinical term is correct in context is a domain judgement.

Sources

FDA — eSTAR ProgramCurrent submission and technical-screening guidance; exceptions and submission-center instructions matter.
FDA — Premarket Notification 510(k)510(k) pathway background; translation completion is not device clearance.

FDA 510(k) Translation: English Documents and eSTAR Checks