Decision Diagnostics Corp (DECN)

[IPwatcher]

Oh dear!

"These screening kits allow users to find out if they are infected before symptoms worsen, allowing for faster and more effective treatment!"

That looks like a Medical Device Claim to me. Not alot of wiggle room.
I think the FDA take a very dim view of medical claims that have not been substantiated!


This looks really bad!


https://img1.wsimg.com/blobby/go/8735ded4-98a4-45d2-93a6-e864c9c614d5/downloads/GenViro!%20Spec%20copy.pdf?ver=1588218173112

According to an appellate court decision: "Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising."

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

and

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=809

(iii) Instructions for a simple method by which the user can reasonably determine that the product meets its appropriate standards.

Oh dear. That last bit appears to be absent!