The recent boom in wellness and medical technology advancements have led to a new division of the FDA’s guidelines, wellness devices. The guidelines aim to help those creating wellness devices and apps to better understand when their product crosses over into regulated medical device territory.
These medical adjacent devices have less FDA regulations and have an easier entry to the market. The vast wellness class has been divided into two categories for general wellness devices that fall outside of FDA regulation. This guidance does not apply to products such as drugs, biologics, dietary supplements, foods, or cosmetics regulated by other FDA divisions. Both low risk wellness device categories promote a healthy lifestyle; whereas medical devices carry more risk.
Medical devices are intended to be used to diagnose, treat, mitigate or prevent a disease. This varies from a simple tongue depressor to complex devices, such as surgical lasers and pacemakers. Medical devices are classified into three classes, which regulatory control increases from Class I to Class III.
- Class I Devices
Class I devices are considered the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control. These devices must establish registration and listing, quality regulation, and proper labeling. Examples of Class I devices include elastic bandages, dental floss and bedpans.
- Class II Devices
Class II devices are simple devices, although they are more complicated than Class I devices. They are also considered to be at slightly higher risk than Class I and require more stringent regulatory controls to provide assurance of their effectiveness and safety. These devices must comply with precise labeling and mandatory performance standard guidelines. Examples of Class II devices include syringes, pregnancy test kits and powered wheelchairs.
- Class III Devices
Class III devices are the most complex devices and highest risk, which require FDA approval before they are released into market. Special controls are strictly enforced to assure labelling, performance, testing, and accuracy is aligned with the product. Examples of class III devices include implantable pacemakers, heart valves, and breast implants.
Intended to only be used for general healthy lifestyle, wellness devices present a minimal risk to the safety of the user and to others. This category includes fitness trackers, apps that track fitness and/or diet, exercise equipment and video games. The wellness device market is expected to reach $612 billion by 2024, according to a recent report by Grand View Research, Inc. The FDA reports two distinct categories for low risk general wellness devices that fall outside of FDA regulation:
The first group of wellness devices are those that do not make any reference to diseases or conditions and instead make general claims. These claims are typically related to weight management and physical fitness, including products intended for recreational use, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
The second group of general devices outlined by the FDA are those that reference specific diseases or conditions, but only do so in two explicit ways. They either claim to help users reduce the risk of certain diseases and conditions, or they may help users better live with and manage the disease or condition. Both subcategories of disease-related general wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes.
There are important distinctions between medical and wellness devices. The FDA now defines wellness devices and creates a clear path for the products to be identified and regulated as either wellness or medical. The massive growth of the wellness and medical device industries has led to a need for developing of the applicable standards, which help medical and wellness device manufacturers through the maze of an ever-increasing volume of standards and regulations. As always, manufacturers need to stay informed about the changing regulatory landscape, as well as the standards and regulations under development.
Learn more about how the FDA regulates wellness devices: FDA