Vivos Inc (RDGL)

[DreDiZzlE]

Fda examples of risk classification.


Class I – Lowest Risk
An example of a Class I device is a manual toothbrush. Class I devices are subject to general controlsClass II – Moderate Risk


Examples of Class II devices are male condoms and non-invasive blood pressure monitors. Class II devices are subject to general controls and special controls

Class III – Highest Risk
An example of Class III device is a heart valve. Class III devices are subject to general controls and premarket approval

Is the risk level of radiogel (melting injectable radiation ) similar to the risk level of a male condom or non-invasive blood pressure monitors? These examples are straight from fda.gov

Sounds like classification is a problem. Also amic stated this while waiting for their "expected approval" while the denovo was in process:

" If the de novo is declined and if we obtain funding to permit us to continue operations, we will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.  If the Company seeks approval as a Class III device, human clinical trials will be necessary.  Generally, human trials for Class III products are larger, of longer duration and more costly than those for Class II devices.  If human clinical trials are necessary, there will be additional cost and time to reach marketing clearance or approval.  Unless we obtain sufficient funding we will be unable to do the foregoing activities. "