-
Melissa and
Michelle are now connected a year ago -
Amie and
Michelle are now connected a year ago -
Michelle changed their profile photo a year ago
-
Michelle updated their profile a year ago
-
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… Read more
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).
-
Jyothsna updated their profile a year ago
-
Amie updated their profile a year ago
-
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…
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
-
Amie changed their profile photo a year ago
-
Melissa and
Amie are now connected a year ago - Load More
