What is the difference? An overview of “Intended for Use,” “Indications for Use,” and “Instructions for Use?”
Preparing a medical device for its intended market from the initial concept phase through to the final launch and commercial release can be very timely and depends on many factors. Labeling and classification of the medical device product are an essential part of the product development process. As part of the labeling phase, three terms are consistently used to help the end-user understand the purpose and proper use of the product itself. The words “Intended Use,” “Indications for Use,” and “Instructions for Use” are defined as the following.