CytoSorbents Corporation (CTSO)

[Plowmaster]

The FDA absolutely does not validate your clinical data. They review the data submitted as part of the medical device clearance process.

This is a medical device and not a drug. Therefore it would go through the '510(k)' process. This process is used to prove 'substantial equivalence' in terms of safety to a predicate device that has already been cleared ('cleared' not 'approved') for marketing in the USA. Medical Devices are 'cleared', Drugs are 'approved' and there is a big difference in the process they go through. (You cannot state 'FDA approved' on a medical device, it's FDA 'cleared' for marketing)

For CSTO I imagine they would use another filter already cleared by the FDA on the market as the predicate device.

Once CSTO has completed all testing and submitted their 510k to the FDA, it should take about 6-9 months to receive clearance. After which they can begin selling in the USA.