Prepare English supporting documents for a 510(k): source traceability, terminology, attachment checks and submission-specific translation questions.
View the file review example ↓View references (2) ↓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
Provide the device names, model identifiers and terminology already approved for this project. Identify which source controls the wording when the same term appears in labelling, test reports and technical specifications. Refer a conflicting source value or indication to its owner rather than silently choosing one version.
Include figures, units, table notes and cross-references in the file list. If an English version already exists, identify its revision and whether it is an approved reference or a draft. That gives translators and reviewers a common baseline for the agreed document set.
Traceability
Keep each source file name, language and revision with the corresponding English return file. If the agreed scope is an extract, record the included sections and exclusions and retain a reference to the complete source. Link terminology questions to the relevant page or field and the person who can answer them.
Agree the review scope in the project brief: subject-matter review, terminology checks, formatting checks and a written QA record may be specified for the actual file set. Identify who reviews each deliverable and who resolves source questions; do not assume every project includes the same review steps or report.
From reading to a project
Match each source file to its reviewed English return file
Attachment handover register · self-created
- Source baseline
- DEMO-ATT-03 · source language: [confirm] · revision B · included sections listed
- English return file
- DEMO-ATT-03-EN · source revision B · agreed review owner and return format
- References to check
- Model DEMO-M1 · figure DEMO-F2 · source page and attachment references
- Chinese internal review, if scoped
- DEMO-ATT-03-CN：供中国团队内部核对；记录对应源文版本及意见负责人，不作为英文申报附件
Review status: questions to confirm
Confirm the included files
List complete documents or agreed extracts, actual source languages, revisions, figures and appendices. Have the regulatory owner confirm submission scope.
Agree the review work
Name the required subject expertise, review depth and any QA record in the brief. Identify who answers source questions and approves the English return set.
Keep reference copies separate
If a Chinese internal copy is needed for collaboration, state its readers, script and feedback owner. Do not mix it into the English submission set.
Related published experience
NIPRO Medical (Hefei)Chinese → English
Medical-device registration files and technical specifications, in volume.
The NIPRO public case records Chinese-to-English medical-device registration files and technical specifications. It does not identify an FDA 510(k) submission or eSTAR package. The example above illustrates file handover, not a NIPRO document or a clearance result.
List the source languages, actual attachments and revisions, required English return files, terminology references and deadline. Agree the review scope and any written record. Say separately if a China-based team also needs a Chinese reference copy.
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.
FDA’s eSTAR page recommends concise, descriptive attachment names rather than a mandatory naming convention, and states a 124-character attachment-name limit. It also explains that accepted attachments are not limited to PDFs. Check the current instructions before packaging files; an illustrative file register is not an eSTAR template or a submission validation tool.
| 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?
Can we translate only part of a document?
Who reviews life science submissions?
Can a Chinese team also receive an internal reference copy?
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.