Instructions for Use (IFU)

What is an Instruction for Use (IFU)? 

An Instructions for Use (IFU) document for a medical device provides detailed guidance on how to use the device safely and effectively. It includes information such as device functions, setup procedures, operational steps, maintenance, and troubleshooting tips. The IFU should be written in clear, easy to understand language and often includes diagrams or images to support understanding. It also highlights warnings, precautions, and contraindications to ensure patient and user safety.

Tips on writing an IFU:

An IFU is a regulated labeling document. Below are four tips to help you achieve a successful filing.

Use clear and concise language: Avoid technical jargon and ensure the instructions are easy to understand for the intended user, whether it's a healthcare professional, caregiver or patient.

Include step-by-step guidance: Break down the use process into simple, sequential steps with clear descriptions and illustrations, making it easy to follow.

Highlight safety information: Clearly state warnings, precautions, and contraindications to minimize risk and ensure safe operation.

Test the IFU with real users: Conduct usability testing to ensure the instructions are effective, understandable, and aligned with real-world use scenarios.