This Note argues that the FDA should revamp its criteria for regulating medical devices to unambiguously include smart wearables. Specifically, this Note calls for the FDA to amend its definition of “medical device” to focus on what a device is technologically capable of rather than its intended use.
Part I will examine the established legislation regarding medical devices; in particular, it will examine the relationship between FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and argue that when taken together, HIPAA creates a strong presumption that smart wearables should be regulated by the FDA. This Part will also discuss a recent legislative proposal that supports the call for smart wearable regulation. Part II will address alternative approaches for the proper regulation of smart wearables. Finally, Part III proposes a unique solution for regulating smart wearables as medical devices and will discuss various policy implications and will address and rebut counterclaims. Additionally, this Part considers the argument that smart wearables fit within the scope of the FDA’s current definition of a medical device and identifies loopholes that prevent them from being sufficiently regulated. This Part will conclude by providing examples of modernized smart wearables that demonstrate the need for smart wearables to be subject to the FDA’s medical device regulations.
This abstract has been taken from the author's introduction.