I am really interested to see if/how this impacts manufacturers reporting practices, especially considering all of the details are not usually available when the initial report is made. Something to keep a pulse on for sure.

Thanks Felicia! I was considering trying out Calendly – if anyone has experience with Calendly I would love to hear about it!

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).