Published January 21, 2025

There is a saying that the best form of flattery is when someone copies your work. However, as writers we may take exception, because of the time and effort that we put in. As doctoral students, we are taught to use previous research done by others to fill in the knowledge gap. If we are writing blogs or articles, we may use information found on the internet. This is where we need to give credit by citing the author’s work.

Did you know there are writings that it is encouraged to copy your competitor’s work through a policy called Substantial Equivalence Requirement for 510(K) Clearance and from the U.S. Food and Drug Administration (FDA)? These documents are Instruction for Use.

In this blog, we will learn what is Instructions for Use (IFU), its purpose, how to write the document and the responsibilities of the manufactures that produce IFUs.

What is Instruction for Use

Instructions for Use or IFUs is information provided by the manufacturer to inform the user of a device’s intended purpose, proper use, and any precautions. IFUs are used mainly in the medical field, specifically for prescription drugs and medical devices.

IFUs are included in all devices including ones that have the smallest modifications which are intended to improve the quality of the product even if the original is still on the market.

IFUs need to include a detailed description of the device including identifying the differences between similar products even if it was manufactured by your own company.

According to Code of Federal Regulations Title 21, all medical equipment, devices, and accessories sold for clinical use needs to include an IFU. However, the only exception are Class I and Class IIA if it can be used safely without any instructions. An example of Class I products include bandages, handheld surgical instruments and nonelectric wheelchairs. Class IIA products include:

• Blood Pressure Cliffs
• Syringes
• Blood Transfusion Devices
• Powered Wheelchairs
• Contact Lenses
• Software used as Diagnostic Tools

Companies that do not provide IFUs with the product must be able to answer any questions from customers including if the device is safe to use without the documentation.

Note:

If hard copies of IFU are not available, the manufacture must provide it in an electronic form.

Comprising an IFU

All IFUs need to be in a clear, step-by-step instructional hierarchy with headings and subheadings. The information should be presented in the following order:

1. Title – “Instructions for Use”
2. Product Title

• Proprietary Name (If any)
• Nonproprietary name
• Dosage Form
• Route of Administration

Other items to include: 

• Purpose Statement: Informs the patient about the content and why it was created.
• Visual of Drug Product
• Line Drawings
• Simple Illustration
• Photographs
• Ensure each part is clearly identified and labeled.
• Important Information for Patients
• Preparation Instructions
• Administration Instructions
• Storage Instructions
• Disposal Instructions
• Additional Information

It is recommended to use active voice, make the steps short, to the point and use images to illustrate each step.

IFUs should be written in sans-serif style fonts such as Verdana and Arial. The font size should be no smaller that 10pt. The only exceptions are:

• Name and place of business of the manufacture, packer, or distributor
• Verbatim statement: This “Instructions for Use” has been approved by the U.S. Food and Drug Administration
• Date of approval or revision of the IFU by the FDA.
• In these cases, 8pt font or more is sufficed. 
• INSTRUCTIONS FOR USE should appear in all uppercase letters and in bold.
• Product title, Headings, Step numbers and Figure titles should appear in bold.

For more guidance on drafting an IFU refer to Instructions for Use  - Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biological-Device Combination – Content and Format which is available online.

Responsibilities and Liabilities

Manufactures can be held liable for injuries that are caused by the unsafe use of the product due to unclear or misleading instructions to include using erroneous information in translations. To be a successful in today’s world, organizations need to create online help documentation to help answer the questions that clients have.

Differences between a User Manual and IFU

The differences between a user manual and an IFU is that user manual is a comprehensive reference on how to operate and maintain a product. User manuals may provide design theory and include information that would be found in separate guides and instructions.

As mentioned above, an IFU is a procedure using to accomplish a specific task. These instructions can be contained in a user manual or as a standalone document. A great example is the user manual is used to operate a medical device, while an IFU focuses on performing tasks on said medical device.

Summary

As a writer, we may be asked to create an IFU if supporting the health industry. These instructions are vital not only to the manufacture’s products but also to our lives. When you have a second just look at any prescription drug, vitamins, blood pressure kit, etc. The directions are IFUs which may save a life and prevent injury to include death.