Replies to post #78202 on Decision Diagnostics Corp (DECN)

[HFM2]

FDA is in no rush to grant an EUA Authorization for any self-administered home testing.

You should read carefully the PRs in which the wording is contained. The first test for which DECN has applied is not a self-administered home test. They were not even planning to submit the EUA until around May 1 (men-yah-nuh). The first test is the GenViro Swift (professional use only) kit, and this part of the plan has not varied since he realized the at-home test was not the FDA's primary concern.

Plus, the wholesale price of the GenViro Swift (PRO) kit has been $6.95 over most of the recent PRs. He has regularly indicated the retail price would be higher.

When you quote "GenViro" you have not been nearly specific enough. It's like saying "I own a Honda."

[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!