Hey all -
For some time we have had a new variance process in the works which really redefines, and IMHO enhances, the entire variance experience as it has existed.
I wanted to post this here for two reasons:
First - and least importantly - I knew that word would soon get around and questions/speculation/criticism would arise in the absence of definitive information. So I wanted to head that off at the pass by being totally upfront especially with this community who cares so deeply about these sorts of issues.
Secondly and much more importantly I have really grown to respect this community of laserists and I wanted to share it with you before it hit the PR wires. I could not think of a better place to roll out such a significant series of developments - at least for those of us working and doing business in the US.
Moving on, I want to continue the pre-amble by making two points:
1) I am happy to answer many questions BUT there are things that I am just not going to post. This new process gives us a significant competitive advantage over other manufacturers, some of whom are members here, and frankly we both worked our butt's off to get this done and set a very, very high bar for anyone else who may give it a go so I am not going to be going into certain specifics which would make it easier for someone to replicate the program.
2) Maybe I have overestimated the significance of all of this in my own head but I suspect that there are going to be some people who are irritated if not angry that these developments were allowed... especially with me not answering certain questions about why and how they were allowed. I will just say that we did the work, blazed the trail and there is nothing in the world stopping anyone else from doing the same if they are willing to put in the year worth of time, tens of thousands of dollars and creativity that we did. As such there is really no reason to be bent out of shape - if that would in fact be anyone's reaction.
Ok - so enough of that.
Here is the new deal:
Part I: Under a complex and comprehensive process which includes literally every aspect of our business as well as several new ones, we sought and subsequently received approval including modifications to our manufacturer's variance to be able to sell high powered laser projectors to individuals and firms who do not hold variances at the time of the sale.
A requirement of every manufacturer's variance is that purchasers must have an active FDA variance at the time of the sale, prior to product being delivered. Under our process, users will still need a variance eventually, but this makes it much easier to compete with the illegal Chinese product thereby tackling the problem of non-compliant product from the demand side.
One of the things I will not go into at present is the robust series of safeguards we have put in place to make this possible from both a manufacturing and distribution perspective. However, it is important to note that we have established a supra-compliant series of procedures - most of which are invisible or wholly unremarkable to the user - that in virtually every scenario will make this new process SAFER than that which presently exists. That is not just my opinion, it is also the opinion of the CDRH.
Part II: X-Laser variances can now be applied for fully and accepted directly on our website. Using some custom software, two commercial solutions and leveraging existing Federal law we have made the entire variance process paperless, highly secure, fully traceable, encrypted and completely legally binding without ever touching pen to paper. User variances are now submitted instantly... which leads me to the last development.
Part III: Because of the security measures built into this system which make it virtually impossible to forge, copy, or otherwise make use of the variance package except within the context of this system, our new 16 page stock variance package has been reviewed and approved by CDRH. Because the FDA is guaranteed to receive identical encrypted submissions with zero deviation and because of one other major factor, our EZ Variance Kit will now virtually eliminate the many months of review time that has become the norm due to the CDRH's workload. I must note that a user still has to receive their approval letter as per usual but that should happen dramatically faster than ever before.
For what it is worth the CDRH put a lot of very reasonable requirements on us even with this system detailed as it was. They are hugely overworked and are genuinely, IMHO, doing their best to keep the industry safe, compliant and free from unnecessary intervention. There is a lot going on behind the scenes and some changes taking place which will make this a better industry for us all and for all of the griping that we ALL do about the turnaround speed and accessibility we really do collectively owe them some thanks for what is otherwise a pretty thankless job. It takes a lot of fortitude to show up for work everyday when you know that hundreds of people are at least irritated with you - whether right, wrong or debatable - and stick to your guns to do what you think it right. This was not a gimmie for us, we had to push the boulder up the hill and while I would really love to share all that was involved I hope that everyone can appreciate if not respect why I cannot.
As I said before, I am happy if not eager to answer questions or respond to comments and in the coming months we will be taking a look at how we can make this system, or some variation of it, available to any domestic manufacturer of compliant high power laser products. That will be a challenge but at the end of the day the more compliant systems we all get into the market in a responsible fashion, the lower the chances of a major incident occurring ( ala Russia) which taints the industry as a whole.
Remember, you heard it here first!