How do we define the “general purpose”?

Abstract: The intended purpose of a device is a key reference when regulators decide whether or not to regulate it as a medical device. However, when coming into consumer health domain, it is sometimes difficult to decide whether a device (or system) has a general purpose or not. The authors discussed the regulatory policy around health device connectivity, operating system and software market, and proposed to regulate them with enough granularity. [Copyright &y& Elsevier]