CytoSorbents Corporation (CTSO)

[Murph1953]

Re: 337 Devices May Now be Exempt from US FDA 510(K) Requirements
March 14, 2017


In layman's terms how - in time and money savings - would the 510(k) exemption impact Ctso.

It's been a long time. I'd given up on the FDA.

I assume this would quicken the time to market (USA, cardio').

What is 21 CFR part 280?

What approximate horizon could we be talking about? Care to make a rational guess?

Thank you very much,

Murph