Does RTM require the use of a medical device?

Medical device requirements for RTM services: what healthcare providers need to know

Short answer: Yes.

As healthcare providers embrace  services like Remote Therapeutic Monitoring (RTM), understanding the requirements for using medical devices is essential. One common question is whether RTM requires the use of a medical device.

Medical Device Requirements for RTM

RTM does require the use of a medical device or Software as a Medical Device (SaMD). These devices or software must meet the definitions outlined under the federal Food, Drug, and Cosmetics Act. Examples of medical devices used for RTM include wearable sensors, remote monitoring systems, and mobile health applications.

Role of Software as a Medical Device (SaMD)

In addition to traditional medical devices, RTM services can also utilize Software as a Medical Device (SaMD), such as Exer's mobile applications. SaMD refers to software that performs a medical function without being part of a physical medical device. These applications can analyze data collected from patients, assist in diagnosing conditions, and provide recommendations for treatment, making them suitable for RTM services.

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