CytoSorbents Corporation (CTSO)

[Plowmaster]

Just my opinion, but it should be a Class II medical device and go through a traditional 510(k) process. There are many filters already cleared in the 510(k) database they could use for substantial equivalence. (The 510(k) process is purely about public safety and efficacy so as long as the primary mode I.e. Filtration is in the same league as other filters they should be able to compare)

PMAs are for drugs and class III medical devices. Medical devices that don't have a predicate device to be compared to are bumped automatically to Class III even if they end result is a class I or II. (There is still a workaround called a 'de novo' 510(k) but I won't get into that)

PMA (pre market approval) is an 'approval' process takes a few years and a couple million dollars. They are a major deal and most medical devices will avoid this route. I really do not think they need this.

510(k) is 6-12 months and about $250k (when all said and done, actual submissions fees are only a few thousand)

For perspective: The number of 510(k) s cleared in a year is usually about 3000, the number if PMAs is only about 20.

My main concerned cited earlier is having to go through CBER vs CDRH. CBER is a pain to deal with and asks for a lot more data and are not efficient at all.

Again my opinion. I am a director of Regulatory affairs and QA in medical device / clinical in Silicon Valley. I work in genomics / Next Generation Sequencing if that helps boost my opinion. :p