Software as a Medical Device (SaMD) is a regulatory compliance category for a standalone software application that is designed to complete a medical task. The SaMD category provides standards for medical apps that were designed for use on general purpose computing devices, such as smartphones or tablets.
Practitioners can use SaMD for many purposes, including the following:
- Using a smart phone's accelerometer to monitor alterations of balance immediately after a stroke.
- Viewing an MRI or other type of medical imaging on a tablet PC.
- Editing digital images to detect cancer.
- Creating and documenting an action plan for treating a specific patient.
- Monitoring body mass index (BMI) or heart rate.
Software as Medical Device regulations
In the United States, Medical Device Class (MDC) hardware is regulated by the Food and Drug Administration (FDA). The goal of establishing an SaMD category is to allow software to conform to the same reliability, security and safety standards as dedicated MDC hardware.
The class to which a device or software app is assigned determines what type of clearance it requires before going to market. In late 2017, the FDA issued guidance for SaMD based on the International Medical Device Regulators Forum (IMDRF) document SaMD N41. The decision of whether to classify a software app as SaMD is up to the vendor.