Class II Device IFU Translation for FDA 510(k)
Translated IFU, labels and packaging copy for a Class II device US export aligned with 510(k) timeline.
Hintergrund
A first-time 510(k) submitter needed Chinese IFU and labels in FDA-appropriate English—warnings, contraindications and UDI aligned with source and US label artwork.
Ergebnisse
FDA consultant confirmed warning and UDI language meets 21 CFR expectations
Leistungen:
Sprachen:
Projektherausforderungen
Warning conventions
Warning hierarchy and symbols per FDA practice.
UDI & models
Model and lot rules unchanged.
Figure alignment
Illustrated steps mapped line by line.
Filing window
Final lock before 510(k) submission date.
Unser Vorgehen
Phasenweise Lieferung mit Balance aus Qualität, Compliance und Termin.
Regulatory alignment
Confirm target markets, doc types and authority expectations.
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
Med TEP + DTP
Medical linguists, second review and layout fidelity.
Submission packaging
Organized deliverables per filing templates and change logs.
Deliverables
Project highlights
510(k) experience
Common IFU structures and review focus areas.
Warnings
Professional warning hierarchy handling.
Label sync
UDI and packaging copy aligned.
Final lock
Version tied to submission package.
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