[Melissa]

Hi@AmieSmirthwaite – I definitely agree with Holly to check out FDA’s guidance for general wellness. When you consider regulation and classification of many of these types of devices in the US, the question often becomes whether or not the organization marketing the device has vetted their regulatory strategy (as a class I, 510(k) exempt or other exempt device, for which a premarket application is not required) with the FDA (via a pre-sub or 513(g)) or if they have self-classified their device and are not on FDA’s radar. It becomes an interesting topic of conversation as to how to approach a regulatory strategy for clients with a “me too” type of technology. With regard specifically to general wellness devices, I wanted to note that FDA has started to sit up and take notice to these types of devices and standing on enforcement as medical devices. MD&DI published a nice article related to the WHOOP device and the regulation of wearable technologies as medical devices. You can find the article here: FDA Issues Warning to WHOOP: Blood Pressure Feature Faces Medical Device Regulation Challenges in 2025