Who Wants to be a Wellness Device?
As a medical device innovator, marketing your wellness product in the US can be challenging.
Having complete assurance of whether your device truly qualifies for this type of marketing is difficult and confusing.
In this blog series, we’ll break down the qualifications, claims, and other related elements for marketing a device as a wellness product.
What is Wellness?
The definition of wellness covers a broad number of products that change with the current health trends— so, a concrete definition may be unclear.
Currently, the Center for Devices and Radiological Health (CDRH) defines general wellness products as those that meet the following two factors:
- are intended for only general wellness use
- present a low risk to the safety of users and other persons.
Watch our team share the definition of a wellness device and discover if you could have a wellness device, here:
What does the guidance say?
The FDA guidance on wellness products provides a detailed look at what makes up a wellness product and can be found here.
Don’t feel like reading the guidance?
To sum it up:
The product has a wellness intended use that relates a healthy lifestyle and has better outcomes for a condition or state of being, and
The product’s intended use expresses this relation as “may help to reduce the risk of” or “may help living well with” a chronic disease.
Well, what does that REALLY mean?
Basically, if your device presents a low risk to the user and promotes self-care and a healthy lifestyle— it could fall under the umbrella of wellness device enforcement discretion, which serves as more of a ruleset than regulation.
Another thing to keep in mind when determining whether your device could be considered wellness is the wording used to describe its intended uses and marketing claims.
Wording like diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, automatically EXCLUDES devices from the wellness designation.
Use the following checkbox to determine whether your device meets the criteria of wellness products:
Figure 1: Wellness Classification Checklist
Keep in mind, in order to be a wellness device your product must meet the following requirements:
But what are the benefits of being wellness?
As the US becomes more aware of self-care and healthy lifestyles, the market for wellness products, especially devices, grows.
In 2021 the wellness market is booming, and companies want to take advantage of this trend and develop products to meet the needs of this space.
Not only are wellness devices capitalizing on an upward trend to meet consumer needs, but the wellness label also offers a faster approach in getting these specific type of products to market.
What does this mean for the development of my product?
The wellness designation offers a faster pathway to market because it doesn’t have the same requirements as other product types that require submissions like a 510(k).
Think You Have a Wellness Device? What's Next?
If you are a device manufacturer that wants to sell a product on the US market, a good first step is reviewing the claims and marketing around your product.
If the product meets the FDA-defined characteristics definition, your product could be wellness in nature.
If you need help identifying whether your product meets the needs of a wellness device or if you need help polishing the language used in your marketing, Proxima CRO can help.
Reach out today for a Wellness Device Assessment of your product, to get a better understanding of wellness, or to get answers to any regulatory questions you may have.
Look out for future blogs in Proxima CRO’s Wellness Device Playbook series— as we will address intended use and claims, risk, and marketing as a wellness device in greater detail in future articles.
References
- U.S. Food and Drug Administration. 2019. General Wellness: Policy for Low Risk Devices - Guidance. [online] Available at: <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices> [Accessed 7 September 2021].
- Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, 21 C.F.R. § 807 (2020).
- Labeling, 21 C.F.R. § 801 (2020).
- Labeling for In Vitro Diagnostic Products, 21 C.F.R. § 809.10 (2020).
- Quality System Regulation, 21 C.F.R. § 820 (2020).
- Medical Device Reporting, 21 C.F.R. § 803 (2020).
- Medical Device Reporting, 21 C.F.R. § 803 (2020).
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 (2021).
- https://www.betterup.com/blog/22-new-wellness-trends-that-should-be-on-your-radar
