Intended use

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Intended use refers to the purpose for which a medical device is intended to be used, as specified by the manufacturer on the labeling or in the instructions for use. The intended use includes the medical conditions and/or diseases that the device is designed to diagnose, treat, prevent, cure, or mitigate, as well as the patient population for which the device is intended. The intended use also includes any specific claims or statements made by the manufacturer about the device’s performance or effectiveness. The intended use is an important consideration in the regulatory process for medical devices, as it helps determine the appropriate regulatory pathway and requirements for the device. It is also critical for ensuring the device is used safely and effectively by healthcare professionals and patients.