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CATEGORY: DOCUMENTATION
Instructions for Use (IFU)
The document provided with a medical device containing instructions for safe and effective use. IFU must include intended purpose, contraindications, warnings, precautions, and directions for use. Required in all jurisdictions.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Instructions for Use (IFU) accompany medical devices to enable safe, effective use by the intended user. IFU content is regulated labeling—not marketing copy—and must stay consistent with the cleared/approved intended use and risk file.
PROCESS / STEPS
- Define intended users, use environments, and critical tasks (human factors inputs).
- Draft IFU sections: intended purpose, indications, contraindications, warnings/precautions, step-by-step use, cleaning/reprocessing if reusable, storage, and disposal.
- Align IFU with risk controls (ISO 14971) and clinical evaluation claims.
- Localize languages required by target markets (e.g., JP/CN/EU languages).
- Control revisions under document control; update after design/labeling changes and FSCA.
EXAMPLES
- Reusable surgical instruments need reprocessing instructions validated to standards.
- SaMD IFU often include cybersecurity, update, and clinical decision-support limitations.
RELATED GUIDES & TOOLS
SOURCES
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