What does the term "intended use" refer to in regulatory affairs?

The term "intended use" in regulatory affairs specifically refers to the objective intent of the manufacturer regarding how the device should be used, which is clearly reflected in the labeling of the product. This definition encompasses the specific indications for use, the population for whom the device is intended, and the conditions under which it is meant to be used.

Correctly defining intended use is crucial in regulatory submissions because it helps regulatory bodies assess the product's appropriateness for market approval and ensures that the device meets the necessary safety and efficacy standards. The intended use directly influences the classification of the device, the regulatory pathway, and the claims that can be made in marketing materials.

Understanding the intended use is vital for compliance with regulatory requirements, as it shapes the entire lifecycle of the device, from development through advertising, and even into post-market surveillance. This highlights the importance of clear communication from the manufacturer regarding how they envision their device being utilized in the real-world setting, which is encapsulated in the labeling.