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Medical device?
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Medical device?
This product was advertised to me on X/Twitter: http://www.humehealth.com – the health claims on X were pretty explicit (eg “early warning of health problems”). They seemed to have toned it down somewhat on their website, but I think some of these claims still put them into medical device territory in the EU… but I cannot see anything resembling a CE mark, even though it appears to be for sale to anyone anywhere. What’s the situation in the US with products like this?
humehealth.com
Hume | Better Metabolic Health - Tap Into Your Body's Data
Reclaim your health by unlocking & understanding your body's data using powerful in-home health devices & our intuitive app. Make better choices through smart bio-hacking and AI powered insights
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2 Replies
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Hi @AmieSmirthwaite I would definitely take a look at FDA’s guidance on general wellness devices (here’s the link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices) to ensure that it truly meetings the definition of a general wellness product. There has been a lot of activity with devices in this space getting warning letters from FDA because its their position that they did not meet the definition! As warning letters are public, they can create huge issues for investors, stocks, etc (even if the issue ultimately gets resolved with FDA).
fda.gov
General Wellness: Policy for Low Risk Devices - Guidance
This guidance provides clarity on FDA's compliance policy for low risk products that promote a healthy lifestyle (general wellness products).
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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
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