A new Beginning..., page-2877

G'day @dman0
Trust you are having a great weekend!
My thoughts in relation to the above you posted yesterday:

So I have done some more research and these are the fruits of my labor: The 120 days stipulated is a little controversial I'll explain why - - In this report "secrets of the denovo pathway" published on February 5, 2014 it states that 120 days is the time it takes

"Today’s Slimmed-Down De Novo Process
The good news is that, within the last year and a half, Congress has enacted changes to the de novo regulation that, at least in my opinion, have made the pathway much more attractive for medical device manufacturers — at least for certain kinds of applications. Basically, FDA has simplified that process, streamlining it into what some people are calling “the new de Novo process” (even though it’s substantially similar to the “old” de novo).

Now all manufacturers of low-risk devices have to do is simply submit a request to FDA for de Novo classification, right out of the gate. No longer do they need to first submit a 510(k) and have it rejected. They go straight to FDA and say they have a new device with no precedent, but that it shouldn’t be considered Class III and here’s why. (Again, here’s where a good risk mitigation strategy comes in.) The FDA then has 120 days to issue a classification. This streamlining of the process should, in my opinion, reduce review times and increase the popularity of the de novo pathway moving forward."
https://www.meddeviceonline.com/doc...t-why-aren-t-more-device-makers-using-it-0001

Clearly the whole process before the initiation of this rule came into play took many moons longer as previously companies had to apply for 510 K first then reapply for a de Novo request for novel devices.

" The ideal review time stipulated by the de novo regulation is less than 60 days. However, in 2010 the average turnaround time for a de novo device was 241 days.

WOW 60 Days!on some sites the average states that it takes around 150 days not 120 days the reason being is because of the slow turn-around times prior to 2010 IMO. So as the years progress the overall average continues to decrease as the deadline is 120 days. This is the way I take it @dman0. You can bet your bottom dollar that our company has already been in discussion with the FDA. I called T K yesterday to confirm all of this. He informed me that just like CE there is a discussion and questions are asked that the company properly responds to. Every time a question is asked the 120 day clock stops. Obviously it's no walk in the park getting a first-of-its-kind class ll device through to the FDA or Class lla through to CE of course there are going to be questions they're not just going to stay silent bend over and tick our box without questioning things IMO.

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) removed the 510(k) prerequisite, allowing manufacturers to petition directly for a risk-based classification into Class I or Class II.

https://www.medtechdive.com/news/fdas-de-novo-pathway-is-about-to-get-a-makeover/542945/

Here is another page that stipulates 60 days...

"If you can submit an acceptable de Novo application where the necessary performance testing is completed, the risks to health have been mitigated, and the special controls have been identified, then FDA aims to have a decision to you within 60 days. When deciding whether the de novo pathway is right for your company, be sure to do your homework and regulatory research to show that your device is de novo eligible."

https://www.acknowledge-rs.com/blog/2016/6/8/the-de-novo-pathway-is-it-right-for-my-device


So fellow investors in summary I believe from my research that 120 calendar days is when a decision can be expected from lodgment. If there is plain sailing and absolutely no questions whatsoever then the clock won't stop ticking so therefore maximum days should be 120. How many clock stoppages have there been in between is anyone's guess and how long did it take for our company to respond to any questions? Will there be any further questions?. If we knew the answer to that million-dollar question we would know around what day to expect the announcement.. From the 13 of August is exactly 120 calendar days since lodgment took place.. IMO shouldn't be too much longer after that date for our potential de Novo application to be granted by the FDA.

IMO things should start heating up and a bit of fear of missing out should start to kick in as of next week... remember RAPpers - experian group our consultants have a 99% clearance rate, 99%!!!
All the very best to all and hope you all have a fantastic weekend...

Cheers

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