Preparing Instructions for Use (IFUs) for FDA Submission for Medical Devices
Preparing Instructions for Use for FDA submission can feel overwhelming at first. That feeling makes sense, because an IFU for a medical device is not just a manual but a regulatory document the FDA expects to meet very specific standards. When prepared well, it demonstrates that your medical device is safe, reliable, and designed with the end user in mind.
Many companies ask the same questions when preparing IFUs for their medical devices: What exactly do we need to include? How should the information be presented? And how can we make sure everything meets both FDA requirements and global standards? Let’s walk through the essentials so you can move forward with clarity.
Legal Requirements: FDA Rules
The foundation for any IFU in the U.S. is 21 CFR Part 801, which defines FDA’s labeling requirements. Every IFU must be in English, factually accurate, and written so that the intended user can operate the device safely. Class and type of device can influence additional content requirements.
For example, a home-use glucose monitor must include instructions on calibration, interpreting results, and safe disposal of test strips. Clear, simple wording ensures accessibility for non-technical users.
Content Requirements: What Needs to Be Included
Standards such as ISO 20417:2021 outline the information that should be included in an IFU. This typically covers product name, intended use, contraindications, storage instructions, warnings, and limitations.
Take an infusion pump: its IFU must specify flow rate limits, alarm details, and maintenance steps. Without this, FDA reviewers may reject the submission as incomplete.
Usability and Structure: Making IFUs Easy to Follow
Content alone isn’t enough. The way information is organized matters. IEC 82079-1:2019 provides guidance on writing and structuring instructions so they are user-friendly. Logical flow, consistent terminology, and visual support are central to this approach.
For instance, an implantable device system may need a step-by-step guide to assembly, sterilization, and implantation. A well-structured IFU minimizes the risk of user error in critical settings.
Safety Messaging: Communicating Hazards Clearly
Safety warnings should be more than simple notes. They should follow a clear format. ANSI Z535.6 establishes how to present hazard information with a signal word, hazard description, avoidance steps, and consequences.
For example, an in vitro diagnostic kit should instruct users on handling reagents safely and describe the risks of contamination if steps are ignored. Standardized safety messaging makes IFUs defensible during compliance checks.
Translation and Localization Considerations
If your device will be marketed internationally, multilingual IFUs are often required. The FDA requires English, but regulators in Canada and Europe will expect localized versions. ISO 17100 provides a framework for translation quality. Using translators with medical expertise and pairing symbols with text where needed ensures clarity across languages.
A common mistake is leaving translation to the very end. Instead, build it into your compliance planning from the start to avoid delays.
Common Pitfalls to Avoid
- Copying IFUs from other markets without adapting to FDA rules
- Using overly technical language that confuses lay users
- Omitting safety warnings or instructions unique to U.S. regulations
- Treating translation as an afterthought
Key Takeaways
- FDA rules (21 CFR Part 801) set the legal baseline.
- ISO 20417 defines essential IFU content.
- IEC 82079-1 ensures clear structure and usability.
- ANSI Z535.6 standardizes safety messages.
- Translation and localization should be part of early planning.
FAQs on Preparing IFUs for FDA Submission
Do all devices require an IFU?
No. Some very simple devices may not need one, but most Class II and III medical devices do. For example, a tongue depressor or adhesive bandage may not require detailed instructions, while implantable devices and diagnostic equipment almost always do.
Can I use my EU MDR IFU for FDA submission?
Not exactly. While there is overlap, the FDA has its own requirements, so your IFU needs adjustments.
Will FDA reviewers fix unclear instructions for me?
No. If your wording is confusing or incomplete, the FDA will return the submission for correction. This can add weeks or months of delay. Clear, plain language that anticipates the user’s needs will help avoid back-and-forth with reviewers.
How do I improve my chances of first-time approval?
By aligning with international standards, following FDA regulations, and seeking guidance from compliance experts who know what reviewers look for. Using examples, templates, and structured checklists can also make the process smoother and reduce the chance of rejections.
Moving Forward
Preparing Instructions for Use for FDA submission is a process that requires both technical accuracy and user-focused clarity. At Quality Smart Solutions, we partner with medical device companies to create IFUs that are compliant, well-structured, and ready for review.
Learn more about our Medical Device Compliance Services or Contact us today to start building documentation that helps you succeed in the U.S. market.
