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ashleyfitzsimmons replied to the topic Fitbit Medical Device? in the forum Introduction to Project Management 7 years, 2 months ago
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.