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What Information Does the FDA Expect in Your IFU?

A Practical Guide to Preparing Instructions for Use (IFU) for U.S. Medical Device Marketing Authorization

When entering the U.S. market, a medical device’s Instructions for Use (IFU) is not just a technical document—it’s a legal requirement. As a core part of labeling regulated by the FDA, the IFU must demonstrate your product’s intended use, safety, and compliance. A well-prepared IFU can support a successful FDA product marketing submission, while an incomplete one may delay marketing authorization or create liability issues down the line.

To support the critical IFU preparation task, Hansem Global and Amin Wasserman Gurnani LLP (AWG) offer a joint solution that bridges regulatory content and legal compliance. Hansem Global brings deep expertise in multilingual documentation and usability-focused IFU development, while AWG provides unique legal insights into FDA labeling rules, submission procedures, and enforcement risk. Through our collaboration, we help manufacturers create IFUs that are not only effective but also FDA-compliant, submission-ready, and defensible.

This article outlines 11 essential elements that should be included in your IFU, based on ISO 20417:2021. While the relevance of each item may vary depending on the class and use environment of your device, these items serve as a foundational checklist for any regulatory-ready IFU.  These elements complement FDA medical device labeling requirements at 21 C.F.R. Part 801 for all devices and additional FDA medical device labeling requirements at 21 C.F.R. Part 809 for in vitro diagnostic devices.

11 Key Elements Your IFU Must Include

  1. Device Name, Model, and Manufacturer Information
    • Clearly state the product name and model number.
    • Include the legal manufacturer’s name and address
    • This information must be consistent with product label information, packaging, UDI barcode data, and other regulatory documents.
  2. Intended Use / Intended Purpose
    • Define the medical purpose of the device.
    • Specify who the users are (e.g., healthcare professionals) and in what environment it is used.
    • This section should align with other registration documents and be placed early in the IFU.
  3. Instructions for Use (Assembly, Operation, Maintenance, Disposal)
    • Outline how to safely and correctly use the device, from setup to disposal.
    • Include cleaning, maintenance, and replacement instructions if applicable.
    • Disposal methods must be clearly stated for environmental and safety compliance.
  4. Contraindications and Limitations
    • Identify patient groups, medical conditions, or situations where the device must not be used.
    • Device misuse or unclear device limitations can lead to safety risks or legal issues.
  5. Warnings, Precautions and Safety Notices
    • Use ANSI Z535.6 formatting:
      1. Signal word (DANGER, WARNING, CAUTION, NOTICE)
      2. Hazard
      3. How to avoid the hazard
      4. Consequences of noncompliance
    • Place warnings, precautions and safety noticesbefore the relevant operation steps.
  6. Sterilization and Storage Conditions
    • List the sterilization method (e.g., EO, steam, radiation) and whether re-sterilization is allowed.
    • Provide environmental storage conditions: temperature, humidity, light, vibration, etc.
    • Include consequences of improper storage if relevant.
  7. Device Components and Accessories
    • Provide a complete list of included parts, accessories, and optional components.
    • Use illustrations or tables to support clarity and prevent misuse or information omission.
  8. Environmental and Technical Requirements
    • State power requirements, voltage, frequency, etc.
    • Define suitable usage environments: hospital, home, mobile unit, etc.
    • Place this content in a “Technical Specifications” section or near setup instructions.
  9. Expiration Dates, Manufacturing Info, Customer Support
    • Include the device manufacture date and use-by date if applicable (e.g., for consumables).
    • Provide customer support contact info: phone, email, website.
    • Ensure consistency with labeling and packaging data.
  10. Regulatory Symbols and Certifications
    • Clearly display marks such as CE, FDA listing number, UDI, ISO certificates, etc.
    • Explain symbols used (per ISO 15223-1 or IEC 60417) with accompanying text definitions.
    • This information is typically located in a “Symbols and Regulatory Information” section.
  11. Electronic IFU (e-IFU) Guidance (if applicable)
    • If the IFU is delivered electronically in addition to the required hardcopy, explain how users can access it (website, QR code, app).
    • Clarify access requirements (e.g., login, internet).
    • Ensure compliance with FDA e-IFU policies, especially for professional-use or fixed-installation devices.

Best Practices for Clear and Compliant IFUs

  • One message per paragraph: Users want quick access to specific information.
  • Consistent terminology: Avoid confusing variations of the same concept.
  • Use clear, concise sentences: Direct command phrases like “Press START” are more effective.
  • Rely on illustrations, not color-heavy visuals: Keep diagrams simple and accessible.
  • Repeat warnings when necessary: Safety messages should appear at every relevant stage, not just once.

The IFU is more than a manual—it is a legal, regulatory, and safety-critical asset. Its effectiveness depends on both content and structure. Before worrying about formatting, always ask:
“Is anything critical missing from our instructions?”

Final Thoughts: The IFU Is Where Compliance Meets Trust

The IFU is not a formality. It’s a gateway to regulatory marketing authorization, user safety, and product credibility. By ensuring that your IFU covers the key categories above, you can:
✅ Prevent marketing authorization delays
✅ Build user confidence
✅ Manage product risk more effectively

Why Work with Hansem Global and AWG?

Hansem Global has over 35 years of experience designing user-centric manuals and supporting multilingual localization in 50+ languages across high-tech industries. Our proven documentation processes and structured approach are well-suited to regulated sectors such as medical devices and digital health.

We specialize in helping clients:

• Organize complex product information for regulatory review
• Ensure consistency across languages and document formats
• Navigate multilingual labeling and IFU preparation for global markets

AWG complements this by guiding companies through FDA regulations, submission strategies, and legal risk management.

Need help developing IFUs? Hansem Global and AWG are here to support your team, from concept to global rollout. Through our collaboration, we will help you develop IFUs that are not only readable—but also review-ready, risk-aware, and built to pass regulatory scrutiny. Whether you’re preparing an IFU for FDA submission or localizing it for overseas distribution, Hansem Global and AWG can support your team with planning, writing, design, translation and legal counsel.

Learn more about how we can support your FDA and other regulatory needs: