As you develop and refine the idea for your device one of the most critical things to consider is its FDA classification. According to FDA guidelines, is it officially a medical device or a wellness device? Are you sure?
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There is a growing market for both wellness and medical devices, but as the wellness industry has boomed in recent years, it’s in your best interest to get your device’s classification right as early as possible. This is the best way to prepare for what lies ahead in terms of FDA regulation and approval. Keep reading to learn more.
Why does the difference matter?
Obviously it’s a matter of ethics to accurately represent a device, what it is intended to do, and what it’s capable of. What’s more, marketing and labeling it correctly allows potential users to understand what the device does and does not do, and may help them to manage expectations.
There are also implications for consumer health insurance based on the device type. While some medical devices may be eligible for insurance coverage or reimbursement, wellness devices usually are not, and this is often of interest to patients and consumers.
From legal and business perspectives, there can be severe penalties for marketing and selling an incorrectly classified device, especially if what you consider a wellness device is determined to be a medical device by the FDA. It’s always in your best interest to become familiar with the differences and follow all guidelines and regulations carefully. What follows is an overview of the basic differences between wellness and medical devices.
What is a wellness device?
The definition of wellness devices rests on the widely-accepted notion that making healthy lifestyle choices positively impacts health outcomes. Therefore, these devices are designed to encourage healthy choices and aid in maintaining a healthy lifestyle. Common examples include fitness trackers, game apps that promote mental fitness, and food tracking software.
Wellness devices typically target broad or general things like improving sleep, tracking physical activity, or managing weight. Primary characteristics of wellness devices include the following:
- Not subject to FDA regulations
- Used to promote, track, and encourage healthy choices
- Use poses a low risk to the safety of the user or others
- Makes only general claims about health and wellness
- Not intended to diagnose, treat, or cure a specific disease or condition
- References to specific diseases or conditions indicate that its use promotes wellness for:
- Helping reduce disease risk, or
- Helping manage a disease or condition
The FDA discusses wellness devices here.
What is a medical device?
Medical devices are highly regulated and carefully defined in Section 201(h)(1) of the Food, Drug, and Cosmetic Act. Examples are wide-ranging and include things like insulin pumps, CPAP machines, and pulse oximeters.
Medical devices are defined as follows:
- Subject to FDA regulations
- Used to diagnose, treat, mitigate, or prevent a specific disease or condition
- Carry more risk than a wellness device does to the user or others
- May be invasive or implantable (e.g., pacemaker)
- May use technology that poses a risk to others (e.g., radiation)
- Divided into three classes:
- Class I: lowest risk, requires FDA registration and listing, subject to quality regulation, requires proper labeling
- Class II: slightly higher risk or complexity than Class I devices, subject to performance standards, requires proper labeling
- Class III: most complex devices with highest risk to user or others, requires FDA approval before being brought to market, subject to performance, testing, and accuracy regulations, requires proper labeling
How to make the determination
The FDA provides some tips for distinguishing wellness and medical devices here. You should plan to do some background research on your device concept to answer these questions:
- Does it meet FDA definition of medical device as stated in Section 201(h)(1) of the Food, Drug, and Cosmetic Act?
- Is there an existing appropriate product classification for your device?
- Is your software product considered a medical device?
- Is your device intended for general wellness?
- Does it include drugs or medicines?
Need answers? C3 can help.
At C3 Medical Device Consulting, we realize it’s not so simple to determine the difference between wellness and medical devices. Our experts will review your concept, design, and device intent and help you make sense of FDA guidelines so it is classified correctly. Please contact us to get started!
