A particular product I swear by is the Sleep Cycle app. It is an alarm clock that uses the accelerometers and microphone in your phone to monitor your sleep (by function of breathing patterns and movement). It tracks activity to determine how an individual is progressing through the stages of sleep. By monitoring the sleep patterns, it provides insight to individuals sleep habits and also provides a system for allowing an individual to wake from sleep during the lightest stage, helping to limit grogginess and fatigue upon waking.
According to the FDA, this product would be considered category 1. Its intended use is to promote general wellbeing and does not specify a specific condition that it is attempting to improve.
The simplest general wellness product I can think of is a regular bathroom scale. A device that is used to monitor weight and compare it to what is consider healthy values can encourage people to improve their diets and exercise more. This is one of those devices that have been around for a long period of time, before the FDA made categories for general wellness devices. According to the FDA guidelines, the bathroom scale would fall into the first category of devices.
I may be going out on a limb here, but I think board games could be considered something of a general wellness product. It would be of the first category because games don't reference diseases or conditions (other than operation? - kidding). In general though a board game stimulates our brain. Take pictionary for example. You have to be imaginative and mentally sharp. Stratego requires planning and organization. Chess requires all this as well. Compared to watching TV or playing "violent" video games that as my mother would say is "melting my brain", board games can improve a persons general health. It's even know that if you're alone on a desert island that you need to stay mentally active to prevent yourself from going insane.
I would say the squeezable stress reliever ball can be considered a general wellness product. There are different kinds of them but in general they round soft objects with some kind liquid inside. We squeeze them to help alleviate stress or just get our minds off things bothering us. If you think outside the box they can also be used for hand exercises and strengthening. So the product tries to promote good health for our hands and mind by lessening stress. Since this product doesn’t make any reference to diseases or conditions it would fall under the first category of the FDA’s general wellness product guideline.
Going with the category of mobile applications, food intake trackers would be considered general wellness products. Apps like MyFitnessPal allow you to log what you are eating and drinking in order to determine how many calories you consume daily. This would definitely be promoting a healthy lifestyle with and helping to reduce the risk or impact of certain chronic diseases/conditions. It can help fight off things such as obesity or heart disease and represents nearly zero risk by utilizing the app.
The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health (CDRH) compliance policy for low risk product that promote a healthy lifestyle. CDRH defines general wellness products as products that meet the following two factors: 1-are intended for only general wellness use, as defined in this guidance 2- present a low risk to the safety of users and other persons. A general wellness product for the purposes of this guidance has an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
One product that can potentially be classified as a wellness device (and that I am currently using as I type this post) is blue light blocking glasses. These types of glasses have surged in popularity in recent years as electronic devices which emit harsh blue light have become a staple in many individuals' lives, especially those who heavily rely on computer usage in their career. Benefits ranging from lack of eye strain to better quality sleep have been touted, but unfortunately as of today there is insufficient evidence to demonstrate their actual effectiveness. If more research and studies were conducted that prove these benefits as legitimate, blue light blocking glasses could be classified by the FDA in the 1st category of general wellness device since they would prevent eye discomfort and improve sleep quality with little to no risk associated with wearing them, but are not used to treat or prevent a specific health condition.
Lumbar support devices for lower back pain is something that comes to mind for this scenario. They would definitely be placed in category 2. They are often advertised as being a treatment for a number of symptoms ranging from discomfort when sitting to chronic back pain. Something like this is designed to be used every day when you are sitting in any number of places. They function by providing support to the natural arches in your spice, specifically in the lumbar or lower region of your spine. Back pain most commonly comes from the muscles in the lower back being loaded and activated in a manner that they are not used to. These devices are supposed to keep the natural curve of the spine so that the muscles can relax. Whether or not they are successful will depend on the patient and the use case, but they are definitely designed to promote well being by alleviating lower back pain.
While general wellness products claims are not always reviewed by the FDA (and can be risky), I still think the benefit outweighs the risk. The companies that advertise these products understand the liability of the products they advertise. They undoubtedly test the efficacy and potential harms of the products. I am sure that these tests and experiments are not as rigorous as the FDA is, but it is still something. Some of these general wellness products do work! So if the FDA had to approve every single general wellness product, no one would benefit. General wellness products are risky, but relatively**** safe!
In reference to health and wellness apps, I think period tracking apps for women would classify under the second category, because these apps can track whether or not a woman is pregnant, late on her period for a reason, or is showing regular habits on her cycle. These apps help women keep track of their habits and can help visualize women's cycles on a daily basis. I know a lot of women who use this app to keep track of cravings, their moods, how long their periods are each month, and when to expect it for in the future. Since it's only a tracking app based on user input, it is low risk to the user for keeping their health in check.
When I saw the first post in the thread, the device that popped into my head was the LifeAlert device that are typically used by seniors to get immediate medical assistance in the instance of an emergency when living independently.
I attempted to use the questionnaire at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices to help classify it, but there were some ambiguities that made it unclear for me.
LifeAlert produces 4 devices: (1) the pendant worn around the neck with Alert button, (2) the mobile pendant worn around the neck with Alert button and built in GPS, (3) the HELP BUTTON device that can be attached to surfaces such as shower walls, table tops and etc., and (4) the LifeAlert mobile app that can be downloaded onto non-smart phones as speed dial or smart-phones as a mobile app. http://www.lifealerthelp.com/default.aspx
Question 1 reads "A1. Does the product have an intended use that relates to maintaining or encouraging a general state of health or a healthy activity?"
At first, I'd say yes to this question. I believe it enables seniors to live independent lives safely. This can promote their health and happiness because independence promotes their mental well-being, the device sustains their physical well-being, and it reduces stress created by the fear of potential emergencies.
But, the second part of the question tripped me up. It asks, "Does the product only involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions? Claims in this category include: weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function."
LifeAlert can sustain the general state of health of the customer, but does the FDA consider being a senior a condition? From what I gather, the FDA considers geriatrics a special population when it comes to medicine or food because of the prevalance of certain conditions within that group. But, are those considerations irrelevant because of the nature of the product?
If you think the FDA wouldn't classify the customer base as having a condition, you can then move to A3 and evaluate the products' risks.
If you think the FDA would classify the customer base as having a condition, you'd have to go to question A2 and answer two more questions:
"A2. Does the product have an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions? (In answering this question, the following two questions must be considered together.)
a) Does the product have an intended use that relates to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions, and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition?
AND b) Is the relation between healthy lifestyle and disease specifically expressed as “may help to reduce the risk of,” or “may help living well with,” a chronic disease or condition?"
Based on the questionnaire, I would consider LifeAlert products a general wellness device. But, I could also see some issues with the definition of the condition and the potential health risks of the pendant device. I'd love to hear what other people think or dig up regarding this question.
Mental acuity refers to being mentally sharp. If you’re mentally sharp, you have an excellent memory, and you find it easy to complete different tasks. One’s mental acuity is affected by numerous elements like memory, focus, and the ability to comprehend and understand.
A General Wellness Product can be some natural ingredients like: Caffeine, Matcha, Turmeric, Fish oils e.t.c. Which can improve mental sharpness. Many natural ingredients are proven to affect mental acuity positively. Adding these ingredients to your diet can help nourish your brain and boost your mental sharpness as will your ability to concentrate on tasks without getting distracted.
Especially during this pandemic many of us need to really stay alert and keep our mind active. What better way than a more natural product as a general wellness product to help with our Mental Acuity.
Given the pandemic I’m going to go with number two in your question and consider a product as simple as a mask infused with menthol. As we approach the one year anniversary of the lockdown many of you may have had the regular occurrence of wearing a mask in public and how uncomfortable it may be. A general wellness product in light of the pandemic could be a mask infused with menthol to be able to soothe the nose and the mouth while trying to breath and remain safe while adhering / following CDC guidelines. Something to consider, thank you for your contribution on this timely topic.
A product that fits into category one as a general wellness product is a video game. In particular, I am thinking of systems that contain virtual reality games created to help with stimulation and relaxation. While providing stimulation and relaxation, virtual reality video games also target physical fitness. Though they are not promoting reducing health risks and conditions, they still help in some cases. Under these conditions, virtual reality games fit category one because they improve functions associated with general health that do not make any references to disease or condition. Virtual reality games are low risk and are used across many platforms for training, whether for sports or teaching concepts for different learning styles.
There is a need for college students to find better ways to cope with the large amounts of stress that they face daily. I agree that there is a low risk for the sound and sleep product because if what it is able to do for the students. As it utilizes natural music to help the students rest, the students would benefit from a deeper sleep cycle. It is meant to be an improvement to being able to relax overall. It is not meant to diagnose or replace any sort of sleep-related medications or products.
