I would still say no, the fitbit does not need to be regulated. The CDRH defines a general wellness product as “Products that are intended for only general wellness use and present a low risk to the safety of the user.” The fitbit is a good estimate and accurate to an extent but there’s a reason a doctor will still take their own reading instead of looking at your watch. Because the fitbit is not a medical device, nor does it claim to be. The fitbit is used to promote healthy activity, it does not state claims of life sustaining or improving health. It also does not pose a significant risk to the user. Although the guidelines have changed, I still think regulation would be reserved for those that are determined a medical device.

I say yes it should be regulated by FDA as a Class 1 device at maximum. The reason I state this because when I was taking a class in Medicine and Literature a common theme was commercialization. With commercialization in the medical field, people have information quicker and go to doctors to ask for meds they think will help them because they saw it on t.v. So what I believe should take place is that it gets regulated by FDA as a Class 1 medical device, maximum and be sent to Doctors and EMTs i.e (medical profession and services) how to operate these devices. Also, for critical and life-threatening cases such as heart attacks and narcolepsy should be monitored by doctors so they get reasonable quantitive data that can be used to improve these Fitbit devices.

I think that Fitbit and other fitness wearables don't fall under devices to be regulated by the FDA. The reason being that they aren't truly medical devices as they don't make any medical claims. As a general wellness product Fitbit is marketed towards improving a persons physical health and fitness rather than claiming to help treat or cure some kind of disease or condition. Fitbit is also a very low risk device as it is not invasive and doesn't threaten the well being of the person using it.

Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Although they are not intended to diagnose, people rely on these monitors to make sure their blood pressure is at safe normal levels between doctor visits. If a monitor was not regulated by the FDA it is possible that it malfunctions and gives inaccurate readings while still advertising 99 percent accuracy on the box. This would make it a class 1 measuring device because it is intended to measure a physiological factor and implies accuracy.

Fitbits allow people to monitor their blood pressure constantly throughout the day eliminating the need for another at home test. Given the fact that it is measuring physiological factors and implies accuracy it should also be a class 1 measuring device. If it's not properly monitored people can be misinformed about their blood pressure or other physiological measurements which can accumulate into an issue over time.

Although they don't explicitly make medical claims it is implicitly implied that the physiological monitoring is accurate.

The new generation of smart watches does make it a slight bit confusing about whether or not they should be considered a medical device. The device does not monitor blood pressure but it does attempt to monitor the wearers heart rate. It provides data from the day/wee/work out about where your heart rate was. The device does seem to fit the definition of a class one medical device and it should be treated as so. These devices can cause people to feel comfort about their heart rate, but if the reading is incorrect someone could be having a serious heart condition and be given a false sense of comfort from the watch saying they are okay. These devices are claiming to be able to take a medical reading of a person’s heart rate and should be held to these medical standards. These devices are clearly not a blood pressure cuff or a xray machine but they are a form of monitor the general health. The sensors on a treadmill are considered a medical device and so should the watches.

In correction to my last post, fitbit does not currently monitor blood pressure. However, what I wrote about applies to the physiological factors it does monitor such as heart beat. On the other hand, there are a lot of different wearable devices being worked on currently such as a wearable blood pressure monitoring watch. Any of these physiological monitoring wearable devices apply to this discussion - not just fitbit.

One interesting physiological monitoring device is ovu which monitors fertility. This is both awesome for people who are trying to get pregnant and as a substitute or addition to birth control options. Some people monitor fertility instead of taking birth control. A device like this being inaccurate can result in someone engaging in unprotected sexual activity thinking they aren't currently fertile when they actually are. I personally think since it is measuring something physiological and implying accuracy, even if it comes with a disclaimer that it should not replace birth control, that it still has the responsibility to be registered as a class 1 device.

Does anyone know if this device is classified as a class 1 device? Does anyone know about the classifications of any wearable devices? With wearable devices on the rise it may be helpful and of importance for the FDA to release a statement addressing this. I personally would like to know that devices that I am buying for physiological monitoring are proved to be accurate.

In my opinion the Fitbit should be classified as a Class 1 device as similar device exist in the market. This will help decrease the testing period as their are similar devices that prove that such devices are safe and of low risk.

Ashley, I checked the FDA website to answer your question, and it turns out that the Fitbit has surprisingly been classified as a Class II device!

https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133872.pdf

Any thoughts anyone on why it has been classified as a Class II device?

I was also lately scrolling through the topic and first thing I found that this types of devices are not yet classified under fda but it has drafted to classify in class 1 device and is not going to lay any strict rule on this device sincethey promote health and maintain good living standards.
Although this standards should have come way back.

I think the Fitbit should be classified as a class 1 device. some of this devices still had sensors to collect health-related information such as; heart rate and blood pressure. Which full under general control. But, I think they classified it as Class 2 due to Software involve in this type of calculation. The first department for such a project should be CDRH as it can be a medical device. Marketing for such devices heavily relay on improving health and motivate people to exercise more under the supervision of this devices calculation.

Ap962, interesting discovery. No one previously commented that fitbit should be Class II, yet this is the case. One participant compared it to a device that monitors fertility, which I found a good comparison, yet she concluded that fitbit would only be Class I. I would like to point out that even condoms are classified as Class II, how much more so an electronic version of birth control. Expanding on this, it seems that all electronic devices are at least Class II. I searched on the FDA site and found that while simple color changing thermometers are class I, electronic thermometers are Class II. Similarly, while an endoscope is a Class I device an arthroscope (or electric endoscope) is classified as Class II.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2496
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=4373

Can anyone confirm the claim that if a device contains an electric component it is automatically bumped up to class II? Any thoughts on why adding an electric component would categorize a device as class II?