Medical Devices Are Characterized by Intended Medical Use, Not Physical Nature
A) True - Medical devices are definitively characterized by their intended medical use rather than the physical nature of the article itself.
Regulatory Definition Based on Intended Use
The FDA explicitly defines medical devices based on their intended purpose, not their physical characteristics. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA), a product qualifies as a medical device if it is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body" 1.
The critical distinguishing features are:
- Intended medical purpose (diagnosis, treatment, prevention, monitoring of disease) 1
- Does NOT achieve its primary purpose through chemical action within or on the body 1
- Does NOT depend on being metabolized for achieving its primary intended purposes 1
Examples Demonstrating Intent Over Physical Nature
The regulatory framework makes clear that vastly different physical articles can all be medical devices based solely on their intended use:
- Software can be a medical device - The Apple Watch ECG app, despite being purely software, is classified as a Class II medical device because it is "intended to be used for medical purposes" to monitor heart rhythm 1
- The same physical article may or may not be a device - An app monitoring food consumption for weight management is NOT a medical device, while similar monitoring technology intended for disease diagnosis IS a device 1
European Regulatory Alignment
The EU legislation similarly emphasizes intended use, defining a medical device as any article "intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease" 1.
Key Clinical Caveat
The determination is always made on a case-by-case basis examining how the product is "labelled, promoted or used" 1. The same physical object can have different regulatory classifications depending entirely on its marketed intended use 1. For example, contact tracing apps for public health surveillance are generally NOT medical devices despite collecting health-related data, because their intended purpose is surveillance rather than individual diagnosis or treatment 1.