The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

Is my product a medical device?

March 24, 2022

When you're developing a medical product, you need to determine if your device is a medical device. When you're selling products in the United States, the FDA has jurisdiction over medical devices. Medical devices are subject to specific regulations regarding safety and efficacy. 

To start, the definition of a medical device according to the FDA is found in Section 201(h) of the Food, Drug and Cosmetic Act (FD&C). According to the law, a device is a medical device if it is “intended for use in the diagnosis…in the cure, mitigation, treatment, or prevention of disease” OR “intended to affect the structure or any function of the body…which does not achieve its primary intended purpose through chemical action.” 

From the FDA’s perspective, you need to define the intended use of your device before you can determine if it is a medical device. 

If your device does not meet this definition, it might be a wellness product. Wellness products can be further classified as “general wellness” products - which are devices that make general claims about their function. 

General wellness products can claim to increase relaxation, decrease stress, promote physical fitness, or other general claims. Another type of wellness product makes claims about how they may help with specific conditions - but these claims must be supported by existing scientific evidence. 

For example, a specific wellness product could include a claim that it “promotes physical activity, which can help alleviate high blood pressure.”

If you've got questions about determining whether your product is a medical device, schedule a free consult using the below link and we can help point you in the right direction.


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