Medical Devices Do NOT Have Metabolic Action
B) False - Medical devices are explicitly defined by their lack of metabolic action, which is a fundamental regulatory distinction separating them from medicinal products.
Regulatory Definition of Medical Devices
The FDA's Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 201(h) provides the definitive answer to this question:
Medical devices are specifically defined as products that "do not achieve [their] primary intended purposes through chemical action within or on the body" and are "not dependent upon being metabolized for the achievement of [their] primary intended purposes." 1
This non-metabolic mechanism of action is the key regulatory distinction between medical devices and medicinal products (drugs), which DO work through pharmacological, immunological, or metabolic means 1, 2
European Union Regulatory Framework Confirms This
The EU medical device regulations mirror this fundamental principle:
EU legislation explicitly states that medical devices "do not achieve [their] principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means" 1
The distinction between devices and medicinal products hinges on whether the primary mechanism of action is metabolic/pharmacological versus physical/mechanical 2, 3
How Medical Devices Actually Work
Medical devices achieve their therapeutic effects through:
- Physical means (e.g., mechanical support, space occupation, physical barriers) 2
- Chemical means that are NOT metabolic (e.g., local chemical reactions that don't involve body metabolism) 2
- Electrical stimulation (e.g., vagus nerve stimulators for weight loss) 1
- Mechanical aspiration (e.g., gastric aspiration therapy) 1
Clinical Examples That Illustrate This Principle
Weight Loss Devices vs. Medications
The American Diabetes Association guidelines clearly distinguish between:
Medical devices for weight loss: gastric balloons, vagus nerve stimulators, gastric aspiration therapy, and oral hydrogels (Plenity) that work through space occupation and mechanical effects 1
Medications for weight loss: orlistat, phentermine/topiramate, naltrexone/bupropion, liraglutide, semaglutide - all of which work through metabolic, pharmacological, or enzymatic mechanisms 1, 4, 5
The Oral Hydrogel Example
Plenity (an oral hydrogel) is classified as a device, not a drug, because it:
- Works by physically expanding in the stomach to occupy space and reduce food intake 1
- Does NOT work through metabolic action or chemical absorption 1
- Achieves its effect through purely mechanical means 1
Important Regulatory Caveat
While devices cannot have metabolic action as their PRIMARY mechanism, they may be assisted by metabolic means:
- A device can incorporate or deliver a drug, but the device itself must work primarily through non-metabolic mechanisms 1, 2
- Combination products (device + drug) exist, but the device component still functions non-metabolically 3
The Answer Is Definitively FALSE
Medical devices, by regulatory definition across both FDA and EU frameworks, do not and cannot have metabolic action as their primary mechanism. This is not a nuanced clinical question - it is a fundamental regulatory classification principle that distinguishes devices from drugs 1, 2, 3.