Fitbit is a consumer product that has the intention of tracking one’s daily fitness, heart rate, and blood pressure. However, there are people who filed a lawsuit against this company. The plaintiff David Urban bought a Fitbit PurePulse Tracker to monitor his heart rate while training for the marathon. Since Urban had a family history of heart disease, his doctor recommended the Fitbit to monitor his heart rate at home. However, Urban claims that the Fitbit under-recorded his pulse by much as 25 bpm. According to Dr. Vincent Pedre, a physician who practices internal medicine says “if users with cardiovascular diseases rely on a device that under-reports their heart rates, then the user could exercise at a level that puts stress on the organ, potentially leading to a heart attack.” CEO James Park says that Fitbit is not a medical-grade device, but a consumer device. The FDA opted to not regulate what it calls “general wellness devices”.
Therefore, should “general wellness device” such as the Fitbit undergo FDA regulations, since it can affect one’s health if device reading is wrong? Why or why not?
If the “general wellness device” does go through FDA approval, what class would Fitbit fall under? Why?
Center of device & radiological health (CDRH) definition of a general wellness products as
“Products that are intended for only general wellness use and present a low risk to the safety of the user.”
Based on this definition, I do not believe that the fitbit is required to have FDA approval because it is used to track your heart rate as a wellness product rather than a device. Since it is not a device it does not have to comply with the FDA requirements. The fitbit is used to promote healthy activity, it does not state claims of life sustaining or improving health. Even though the slogan states “every beat counts” it does not imply that it is going to help monitor someone’s health.
If the FDA were to consider the fitbit a device then I would classify it as a class 2. The fitbit is very similar to an EKG because they both monitor heart rate. The fitbit would need clinical trials to test if the device is accurate. A class 2 device would need the investigational device exemption (IDE) and a 510k form.
I agree that this should not be classified by the FDA because it does not pose significant risk to the user. The fitbit is an extracorporeal device that is non-invasive and it a general wellness product, like the individual above me has already said. I'd like to expand by also saying that there are other general wellness wearable smart devices currently in the market, so it's not as if the fitbit is the only product to do what it does. If the fitbit is un-calibrated, than that should be brought up with the manufacturer as that is a consumer issue.
If it were classified by the FDA, I would classify it as a class I because similar devices already exist in the market and it could easily be classified by the FDA as being safe and low-risk based on the devices already approved. Clinical trials would not be required in this case as the device does not pose a significant enough of a risk to warrant doing so.
I completely agree with Chaudhry.
According to an article I read regarding the Fitbit regulations decision with FDA, it said that, "According to FDA, the general distinction between a general wellness product and a medical device is whether the product makes a medical claim".
the fitbit is clearly not intended for medical claims. It doesn't tell claim that you have a certain health condition. It is just an aid device to track your overall fitness. If it had to be classified, I will go for classifying it as a class 2 device as there are similar devices intended to monitoring heart rate and clinical studies would be needed.
https://www.advisory.com/daily-briefing/2016/08/18/fda-says-it-wont-regulate-fitbit
I agreed with above posts that fitbit should not consider for FDA approval unless if fitbit claims to treat or diagnose other specific diseases then definitely need a FDA approval and I believe it considers as a class II device and need to fill out 510K form. But as far fitbit only use as monitoring heart rate and FDA opted not to regulate any general wellness device. According to one article, a test concluded very accurate when compared to a chest strap heart rate monitor, but the study was biased due to a small sample size of just two participants which I think a major failure. There always be some differences on measuring heart rate because in medical-grade devices typically worn around the chest to measure electrical impulses that travel through the heart, while fitbit detects blood activities in the wrist to measures one’s heart rate. There were several fitness tracker devices that measured heart activities before fitbit were inaccurate.Those devices like fitbit are only for tracking life activities, but one should not be rely on.
I tend to agree with bb254 and Chaudhry that as marketed by its company, Fitbit PurePulse tracker is pitched as a “general wellness use and present a low risk to the safety of the user.” As long as the Fitbit company didn’t make any medical claims and the FDA had the chance to (but didn’t) regulate the device, the Fitbit company holds no legal liability. Now if the FDA were to consider the Fitbit as a medical device, I agree with Chaudhry and would place it under the Class I. This classification is just due to their being numerous similar products on the market along with the fact that the device itself poses relatively low risk when used correctly.
In addition to what was said above about the lawsuit, if blame was to be placed on anybody/ entity, I would question the physicians judgement of recommending a non-medical device to keep track of a serious medical condition. If the plaintiff turned their attention towards the doctor instead of the Fitbit company, I believe they would have a better chance at receiving compensation for their lawsuit. An actual FDA regulated heart rate monitor would have been a more appropriate option for the patient with a heart condition.
I completely agree with the comments above, the fitbit is not a medical device and it should not be liable to provide " accurate measurements" if you think about the concept of properly monitoring heart beats, the fitbit is a type of device that " one size fits all" so that alone should be a slight indication that it's placement on the wrist will not accurately monitor HBPM. In addition, fitbit company should properly label that on packaging that it is not a suitable replacement for a a heart monitor, just in case another law suit pops up.
Chris
I agree with the posts above that fitbit should not be classified as a medical grade device because it's purpose is not to be used as a replacement for an EKG. The purpose of fitbit and similar activity bands is to give a general guidance on your daily activity and not exact measurement. If it were to be considered a medical grade device it would most likely require a 510(k) since there are similar health monitoring devices out on the market currently that it can be comparable to. I saw an interesting article on a similar dilemma that the apple watch also had when it first came out back in 2015. The main reasoning that was given back then is that the FDA cycles are to long for products to release for these companies which was an interesting point, since 510(k) would create a shorter vetting process for devices such as fitbit and the apple watch. Any thoughts/responses to the cycle being to long holding back innovation?
Link to article: http://bgr.com/2015/11/10/apple-watch-fda-medical-product/
The FDA is currently drafting a guidance to regulate certain "general wellness devices." These include ones that help "log, track, or trend exercise activity" for the maintenance of a healthy lifestyle, exactly what the Fitbit does. Although, with the coercion of top med-tech companies, this guidance is very relaxed and not strictly enforced. Probably for the reasons outlined in all the posts above. That is, it's not a definition medical device and it's more low risk than a "low risk product." However, I feel that the FDA should regulate the Fitbit for the simple reason that it is a lot more than a mood ring. Even though it is strategically marketed as an inconsequential, fun gadget, people take it seriously and incorporate it into their routine. Buying one is letting everyone know you're serious about being healthy. This is the reason they sell; pretending they are not impactful enough to merit regulation is wrong and unfair to the consumer. I agree with several earlier posts that Fitbit should be a Class I product.
Guidelines:
I agree with the majority of the people in that fitbit is not a medical device. It does not pose a risk to the user. It is intended for use in the diagnosis of disease or other conditions. The fitbit does not meet the requirements for a medical device. It does not aid in the diagnosis of a condition. The fitbit is basically a fitness tracker. To answer the question if hypothethically, the fitbit was considered a medical device it would probably be a class I device as it does not pose any risk or harm to the user. As with any class I device, it would have to go through the proper regulations for a class I device.
I agree with most of the participants that fitbit is a device made for consumer use. It is NOT a device that doctors recommend to monitor his or her heart rate and activity. It does not harm or pose a risk to a human being if used with the guidelines provided by the company. Since it’s a consumer device, it does not help in treating a condition. It’s basically for “own use” to see a person activity, such as calories burn, steps taken, and glucose level. If this device were to classify under FDA guidelines, it would fall under Class I medical device since it does not harm a person. Lastly, fitbit is not a heart monitor and doctors should never recommend the use for any kind of treatment.
Further, according to FDA, a “general wellness product” falls into one of two categories, and either:
Has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates 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.
FDA explains that to fall within the first category, the product must not make any reference to diseases or conditions.
FDA provides a number of illustrative examples of products it would consider to be low risk general wellness products, including mobile medical apps that:
- Play music to “soothe and relax” an individual and to “manage stress”
- Solely monitor and record daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health”
- Monitor and record food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity."
So, I agree that fitbit with no impact on any disease.
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
I agree with what has been stated before me. I do not think the Fitbit should be considered for FDA approval; as it does not make any medical claim. This function of the watch is merely there for convenience and for those trying to get a general idea of what their current lifestyle is, and how they can change it to reach a goal. One should not consider on a heart monitor worn on the wrist as medical grade as it’s not that reliable of a location. Listening to the chest or getting a pulse from the neck is a more reliable way. It would be interesting to see Fitbits worn as a necklace to get a more accurate reading, but that takes away the convenience of looking at it while wearing it. At that point you might as well just wear a standard, under the shirt heart monitor.
You would think people would read the fine print of the product to see/realize this is not a medical device that doctors say to use. If doctors did want to recommend the product for official use, the Fitbit would have to get class 1 approval.
According to the FDA the fitbit is classified as class II. It’s funny, something so small such as a fitbit runs on algorithm has to be regulated and considered to be a class II. During my capstone project we also programmed accelerometer that could count a patient's steps and we wrote an algorithm that could tell the user if they are walking normal or abnormal. After looking classification for our accelerometer, we found out that devices like these are considered class II. It is because, like the fitbit it needs to be clinically tested before it hits the market. In my opinion it makes sense, you do not want to buy a device that gives you the wrong data if you are working out. What’s the point.
Due to an error and not being able to make a new forum I am posting here. While the topic is related to Fitbit, the question is not the same.
Should how we use a device define it?
When determining whether a device requires FDA approval, should the common use/assumed use of the device by consumers be put into consideration? If not, should the company be responsible for reasonable interpreted/implied/assumed functions of a device i.e. How it is marketed?
Since the device is marketed as a health monitoring system, and promotes physical activity and is used as a marker/ tracker during those activities, should the device be classified as a medical device even though it's quote unquote intended use is not for diagnostic purposes but only for general wellness. While Fitbit is now a class II device, what about other devices that are used for medical purposes without clearance?
To put this into perspective, if my company, "Medical Grade", manufactured regular scotch tape intended to be used as regular tape, but the product is mainly used in conjunction with cotton swabs to make homemade bandages, should my company have any responsibility should the tape rip someone’s skin off or cause a rash? (note the product is labeled the same way as all other similar products on the market)
Should it be tested the way medical devices similar to it are tested? Where does the line between intended use and actual use fall (if you believe that wall even exists)? I believe that the company must alter it labeling to clear specify that its intended use is NOT the assumed use and that labeling should also reflect the actual use of the product even if government labeling regulations don't require it currently.
