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.
ISO 20417: Defining What to Include
ISO 20417:2021 spells out the key information that must appear in your IFU. This includes the product name, intended use, contraindications, storage instructions, and warnings. If something is left out, your documentation may not get accepted.
Take diagnostic imaging devices as an example. Their IFUs must describe cleaning instructions, probe compatibility, and clinical indications. ISO 20417 provides a checklist to ensure nothing important is missing.
IEC 82079-1: Structuring Information for Clarity
Once the content is in place, IEC 82079-1:2019 helps shape how you deliver that information. This standard focuses on clarity, usability, and logical flow. It encourages you to write in a way that matches how the user will actually interact with the device.
Imagine a dermatology laser system. The IFU should guide users step by step through setup, safety checks, and operation, with visual support when helpful. This standard helps you present the information in a way that is easy to follow, reducing the chance of user error.
21 CFR Part 801: Meeting FDA’s Legal Requirements
21 CFR Part 801 sets out the FDA’s labeling requirements. These rules apply to every IFU submitted for U.S. devices. The document must be in English, accurate, clear, and free of misleading statements. Warnings and instructions should be tailored to the device type and the knowledge level of the intended user.
For instance, a wearable blood pressure monitor must explain how to position the device, interpret results, and maintain it safely. The language should be accessible so the average user can operate the device without confusion.
ANSI Z535.6: Communicating Safety Clearly
ANSI Z535.6 establishes a format for safety messages in IFUs. Each warning should include a signal word, hazard description, instructions for avoiding the hazard, and a clear explanation of the possible outcome if ignored.
This approach is especially helpful for devices where misuse could cause harm, such as diagnostic software that supports clinical decisions. By following a standardized format, safety information becomes consistent, easy to understand, and defensible during regulatory review.
Translation and Localization Considerations
If your device is intended for international markets or multilingual environments, translation quality is just as important as the original English content. The FDA requires IFUs in English, but overseas submissions often need translations that comply with ISO 17100 and are performed by professionals with medical knowledge.
It is also important to use symbols correctly and pair them with text explanations when FDA rules require it. Reviewers will not rewrite unclear instructions. If language is vague, the IFU will be sent back for revision. Translation should be treated as part of compliance, not a final add-on.
Key Takeaways
- ISO 20417 defines the essential content for IFUs.
- IEC 82079-1 ensures information is structured for clarity and usability.
- 21 CFR Part 801 outlines the FDA’s legal requirements.
- ANSI Z535.6 standardizes safety messages. Translation and localization must follow quality standards.
FAQs on Preparing IFUs
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.
