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Holly replied to the discussion Medical device? in the forum IndieMedTech 7 months 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).
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Amie started the discussion Medical device? in the forum IndieMedTech 7 months 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
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Holly started the discussion Happy MedTech Monday! in the forum IndieMedTech 7 months ago
Happy MedTech Monday! Curious to know what everyone is working on this week in MedTech? I have some Notified Body responses, a regulatory strategy, and breakthrough designation request on my to-do list. Thank goodness for caffeine!
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Holly replied to the discussion Day 1 at IndieMedTech in the forum IndieMedTech 7 months ago
Reply to Day 1 at IndieMedTech
Who are you: Holly Cotter, Co-Founder indieMedTech, Principal Consultant at WLC
What’s your focus: bringing together MedTech professionals
What’s one thing you’re looking for in this community: Connecting to new people who I know share my love and passion for MedTech! -
Theresa replied to the discussion Day 1 at IndieMedTech in the forum IndieMedTech 7 months ago
Reply to Day 1 at IndieMedTech
Congratulations. This is an awesome tool!!
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Holly started the discussion Day 1 at IndieMedTech in the forum IndieMedTech 7 months ago
The doors to indieMedTech are officially open, and you’re in on Day 1!
This is where MedTech professionals can swap stories, trade tips, and help each other solve those “hmm… how do I handle this?” moments.
Think of it like your virtual coffee shop for all things MedTech — only the Wi-Fi never drops and everyone gets what you’re talking…
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