Vivos Inc (RDGL)

[DreDiZzlE]

Radiogel as a whole product (y90 and gel etc) is considered a medical device by fda. AMIC will attempt another denovo even tho the fda said they dont consider radiogel moderate to low risk.

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo" --fda denial

Quote from denial saying denovo sounds like a no go.

radiogel is a melting injectable radioactive device. Below are links to fda classification examples. Class 2 devices are low/moderate risk which denovo has to be.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm


fda has examples of class 1 2 and 3 and pretty simple to see radiogel is a class 3 perfect candidate. But class 3 involves human testing which takes years and millions of dollars.

Messages confirming from government agency sources that human clinical trials have been suggested by the fda, but amic will be attempting to submit a high risk product to a low risk category again without the suggested testing.