Sorry i can only post 3 times a day with my free ihub account.
I've got a small position only been here a few weeks. I learned about the stock through Crookedneck. I am looking to add more when I have cash freed up. I never carry more than a couple penny stocks at a time so this and NRTI are it for now.
I would certainly never say '510(k)s' are simple. In fact in many ways they can be more nerve wracking than PMAs.
While PMAs are typically longer and have more requirements the process is 'on rails' PMAs can be more predictable which investors like. Because less guidelines in a 510(k) process around what is required to prove safety and efficacy 510(k) clearance can have many more point battles and variability it in timeline. I can't state how it would affect investors, what would probably be the most negative is if they went 510(k) but were forced into a PMA. Starting out on the PMA path might not be the worst. (100% opinion, and only a educated guess at that)
Remember the 510(k) process is a 'substantial equivalence' process. You are proving your device is equivalent enough to a device already cleared in the 510(k) database it terms of safety. You still have to do all the bench testing, verification and validation and clinical trial (not for every medical device but in this case I'm sure it will be needed) as part of the submission package.
Let's think why this would be a PMA. The FDA might call it class III due to the fact this is directly going into the blood, therefore if their was a contaminant a patient could get hurt easily and they deem the risk high enough. Another reason would be: nothing to compare it to in the 510(k) database. I don't think so though unless they state the filtration technology is so divergent from other filters it is not comparable.
My opinion is still a class II and a 510(k) through CBER. So 9-12 months once submitted.
If we lucky 510(k) through CDRH and 6-9 months.
Reminder:
510(k)s are 'cleared'
PMAs are 'approved'
(Us Regulatory types have to correct folks all the time, especially marketing but it's an important distinction.)
