When preparing a medical device for the U.S. market, the Instructions for Use (IFU) is not just a user manual—it’s a regulatory document subject to FDA scrutiny. A compliant IFU must clearly communicate safe and proper product use while meeting both FDA requirements and international standards.

To support this critical task, Hansem Global and Amin Wasserman Gurnani (AWG) offer a joint solution that bridges regulatory content and legal compliance. Hansem 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. Together, we help manufacturers create IFUs that are not only well-written but also FDA-compliant, submission-ready, and defensible.

This article introduces four essential standards your documentation team must understand to meet FDA expectations—and explains how each standard shapes the content, structure, and legal clarity of your IFU.

1. ISO 20417: What Information Must Be Included in the IFU?

ISO 20417:2021 defines the globally accepted list of essential information that must be included in the IFU and labeling for medical devices. This includes:

• Product name and model
• Manufacturer details
• Intended use
• Contraindications, warnings, and precautions
• Sterilization method (if relevant)
• Storage and handling conditions
• Reuse limitations or instructions

For example, in diagnostic imaging devices like ultrasound systems, the IFU must clearly state probe compatibility, cleaning instructions, clinical indications, and limitations of use. ISO 20417 serves as the foundation for ensuring that no critical information is omitted.

This standard answers the question: “What content is required?”

2. IEC 82079-1: How Should That Information Be Structured?

While ISO 20417 defines what to include, IEC 82079-1:2019 provides guidance on how to organize and present that information for optimal usability. It emphasizes:

• Logical information flow aligned with user tasks
• Modular structure for clarity and reuse
• Use of consistent terminology
• Visual aids and warning placements that match procedural steps

For example, in professional-grade energy-based aesthetic devices, such as RF or IPL systems used in dermatology clinics, IEC 82079-1 helps ensure that step-by-step procedures, device settings, and safety notices are clearly structured and placed in line with user actions.

This standard answers the question: “How should it be presented?”

3. 21 CFR Part 801: What Does U.S. Law Require for IFUs?

21 CFR Part 801 is the FDA’s legally binding labeling regulation. Any IFU submitted to the FDA or otherwise accompanying a medical device in the U.S. must comply with this part of the Code of Federal Regulations (CFR). Among others, key requirements include:

• The IFU must be in English
• Wording must be clear, factual, and not misleading
• Instructions for use must be provided
• Warnings must be included to prevent foreseeable harm
• Specific content may be required depending on device class or type

For example, wearable blood pressure monitors must include clear instructions on proper placement, how to interpret readings, battery safety, and connectivity to companion apps. The language must be understandable to the intended user—often a layperson.

21 CFR Part 809 contains additional labeling requirements for in vitro diagnostic products which are medical devices.

This regulation sets the legal baseline for FDA-compliant documentation.

4. ANSI Z535.6: How to Structure Safety Messages for Compliance

ANSI Z535.6 is a U.S. standard focused on how safety messages should be written and formatted in manuals and IFUs. It establishes standardized formats for conveying hazards using four key components:

• Signal Word (e.g., WARNING, DANGER, CAUTION)
• Hazard Description
• Avoidance Instructions
• Consequence of Not Avoiding

For example, an AI-powered software-based medical device (SaMD) that assists with diagnostic decisions must clearly communicate its intended use—such as supporting, not replacing, clinical judgment. ANSI Z535.6 helps structure such warnings using standardized language, especially when improper use could lead to patient harm or misdiagnosis.

This standard defines how to communicate risk in a legally defensible way.

5. Translation Considerations: If You’re Also Localizing

If your device will be used in multilingual environments (e.g., hospitals with Spanish-speaking patients) or submitted internationally, be aware of the following:

• Use Plain Language for end-user comprehension
• Follow a structured QA process based on ISO 17100 for translation quality
• Assign translators with medical domain knowledge
• If using ISO 15223-1 symbols, include accompanying text explanations where required per FDA regulations

Even when English is the primary language, clarity and consistency are critical. FDA reviewers will not correct unclear language—they will send it back.

Translation is not just a language task—it’s a compliance task.

Final Thoughts: IFUs Are Regulatory Assets

Preparing an IFU for FDA submission requires more than good writing. It demands a deep understanding of applicable standards, user safety principles, and regulatory expectations. To succeed, documentation teams must blend:

• Content completeness (ISO 20417)
• User-centered design (IEC 82079-1)
• Legal compliance (21 CFR Part 801)
• Safety clarity (ANSI Z535.6)

Hansem Global supports U.S. and foreign medical device manufacturers with end-to-end IFU development, technical writing, document design, and regulatory translation.

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

Together, we will help you develop IFUs that are not only readable—but also review-ready, risk-aware, and built to pass regulatory scrutiny.

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

• Brian Cho, Hansem Global – Brian.Cho@hansemgb.com
• Neil O’Flaherty, Amin Wasserman Gurnani LLP – noflaherty@awglaw.com