Intended use of a medical device defines the purpose for which the device is used. In the CE marking as well as in the FDA pre-market approval or notification, intended use is critical as it helps to decide the classification of a medical device or even for the qualification as a medical device. Intended Use is generally the what the manufacturer label claims for what the medical device is used for.
Indication of Use generally describes the reasons or the situations or the diseases for which the medical device is used to fulfill its intended use. It also gives the more detail on the part of the body where it is used which can also be part of the intended purpose. Hence indication of use also affects the classification of the medical device.
Intended Use vs Indications For Use of Medical Device are two distinct concepts that play significant roles in defining the purpose and scope of a medical device. They are essential components of regulatory submissions and labeling for medical devices. Let’s delve into each term:
- Intended Use: The “Intended Use” of a medical device refers to the manufacturer’s intended purpose or function for the device. It outlines the primary reason the device is designed, manufactured, and marketed. This description is provided by the manufacturer and is used to communicate the device’s purpose to regulatory authorities, healthcare professionals, and users.Example: If a manufacturer designs a handheld electronic device to monitor a patient’s blood pressure and heart rate, the intended use might be described as “The device is intended to measure and display blood pressure and heart rate values for personal health monitoring.”
- Indications for Use: “Indications for Use” elaborate on the clinical conditions, patient population, and situations for which the medical device is intended to be used. These indications provide specific context about the scenarios where the device is deemed safe and effective based on clinical evidence.Example: Continuing from the previous example, the “Indications for Use” could state, “The device is indicated for use by individuals aged 18 and above to monitor their blood pressure and heart rate in non-medical settings. It is not intended for diagnosing or treating medical conditions.”
In essence, the “Intended Use” offers a general description of what the device is supposed to achieve, while the “Indications for Use” provide a more detailed specification of when and how the device should be used safely and effectively. Both of these concepts are essential for regulatory submissions, as they help regulatory agencies understand the device’s intended purpose and target patient population. Additionally, healthcare professionals rely on this information to make informed decisions about the appropriate use of the device in clinical practice.
Accurate and clear descriptions of both the intended use and indications for use are critical for ensuring patient safety and aligning with regulatory requirements. Any changes to these descriptions might necessitate regulatory review and approval to ensure that the device’s safety and efficacy remain consistent with its intended purpose.