Labeling and IFU issues frequently trigger NB/FDA questions. Use this checklist to tighten claims, warnings, and usability.
1) Claims and indications
- Ensure claims match verified performance and CER evidence.
- Keep indications/contraindications consistent across IFU, packaging, and digital assets.
- Avoid promotional claims that exceed cleared/authorized scope.
2) Symbols, UDI, and language
- MDR/IVDR symbols per EN ISO 15223-1; UDI placement and readability.
- Country/language coverage and translations with controlled terminology.
- Electronic IFU availability (if applicable) and access instructions.
3) Warnings, precautions, limitations
- Risk-derived warnings aligned to the RMF and verification evidence.
- Reprocessing, cleaning, maintenance, and shelf-life guidance.
- Environmental/storage conditions and disposal instructions.
4) Usability and accessibility
- Readability level, typography/contrast, and layout that match usability findings.
- Clear step-by-step instructions with visuals where needed.
- Human factors residual risks reflected in IFU mitigations.
5) Change control and traceability
- Versioning, effective dates, and linkage to design changes/CAPAs.
- Consistency across paper, PDF, and web delivery.
How MedReg AI helps
- Map IFU and labeling to claims, CER, and risk controls to spot gaps.
- Flag inconsistent claims, missing warnings, and translation coverage issues.
- Generate a gap report you can resolve before NB/FDA review.
For a fast review, run a labeling gap analysis and share with QA/RA. Start via /pricing or contact us at /contact.
