The FDA approved my variance application!!

[blowfly]

Did you mail it or fax it? I got most of my application filled out but am waiting to get the manual reset working before i send it off...

Mailed it. I got another set of letters in the mail yesterday acknowledging receiving the product report and light show report.

I was surprised at the quick turn around. Clearly they put a lot of emphasis on the receival part of the process, perhaps at the expense of the next stage where they actually get around to reading the forms. . I'd be curious to know how many documents they receive a day, I suspect it's more than we would guess.

As far as when I actually get to do shows, I'm not in a huge hurry, but I have trouble with the idea of waiting a year...

Mike

[allthatwhichis]

I thought it was said at the after SELEM "party" that you could start doing shows once you got an acknowledgment from "them" stating they had received your paperwork since it will take so long to actually review it... I was under the impression that is how some who are building certified projectors are currently doing it; they file the paperwork for their buyers when the projector is purchased and the buyer starts doing shows while the Feds review the paperwork filed by the "manufacturer"...

[dsli_jon]

Yo Bro...

I thought it was said at the after SELEM "party" that you could start doing shows once you got an acknowledgment from "them"... I was under the impression that is how some who are building certified projectors are currently doing it..

Well, us (at SELEM, up-to-and-including Casey), *discussing* what is 'practical' vs the 'letter of the law', was one-thing - in-fact, like I said, that is what many Co's are doing - But if you ring-up the CDRH and ask them, they will say "No, you must wait"...

Here's what the guy they've placed in the 'reviews and approvals' chair, (for now...) had to say to one of our system-clients (coloring, mine...) :

On 12/23/2010 1:22 PM, Strzelecki, Woody wrote:

...I would like to add that the Laser Notice 50 offers a clear guidance that the [Band Name] shall not purchase laser projectors until the laser show variance approval is granted.

..and:

On 11/1/2010 12:17 PM, Strzelecki, Woody wrote:

...My search indicates that your company did not receive the necessary variance from FDA/CDRH from 21 CFR 1040.11 c), which would permit your company to engage in this activity.

This was earlier, after I had let him (our Client) know, basically, 'yeah, since you're using a known-Certified Projector, and you have had safety-training / know the Regs, are of the mindset / commitment to 'do it right / safe', etc....since the CDRH can't 'impede commerce', if you've given them 45-60 days, and they have not approved the Variance, (or written-back as-to why it can't be / need more info, etc) well...'ya gotta do what ya gotta do'... But again, that's *not* an 'official CDRH stance'...though it should-be,

We (collectively, within ILDA) are really, really bangin'-hard on CDRH-reform... ie: Patrick Murphy and Greg Makhov were, this past-week, at the CDRH 'Town Hall' meeting, addressing these very-subjects, and, encouragingly, the 'new' Director of Compliance said they 'had made some good points'. He said CDRH has to look at risk assessment in a resource-constrained environment. (...meaning, if audience scanning shows are safer than other products that CDRH regulates, then there is less need for stringent rules.) He said "I will bring this back to the appropriate person, but Jeff Shuren (the Director of CDRH) makes the ultimate call."

So, like Mike said, 'at least we're seeing some progress'...

Also, this Director of Compliance said that the "Office of Compliance wants to know about non-compliant activities". He did not promise that they could take action in every-case, but they *are* aware of non-compliant installs, and Sho-Co's... So, who knows if/when they will 'decide to make an example' of someone.. remember the RIAA-fracass? Yeah, they're monopolistic-devils, but that's small-consolation to the poor woman that got her * sued-into a windsock...

Point-is, *yes* it is good-practice to 'do it right', even-if, w/O the 'paperwork', you might-still do a safe and sane sho... 'CYA' is still a great operating-principal...
But, on the other-hand, once you've got your Acc.# and you've given-them a good wait (at least 45-60 days...) ya do-gotta 'eat', soooo....

Solo mis dos centavos...
j

[allthatwhichis]

Got my docket # today!!! . Only sent mine in a week ago. This is from Document Managment so I think it is for the varience application and not my product report.

[blowfly]

Got my docket # today!!! . Only sent mine in a week ago. This is from Document Managment so I think it is for the varience application and not my product report.

Congrats!!! Yep the docket number is for the variance, you'll get another number for the product report, I think it's called an accession number.

Mike

[blowfly]

The FDA just approved my variance. No kidding. I received the paperwork yesterday with instructions to add the newly assigned variance number to my product label. I am shocked, stunned.. I was prepping for an unbearably long wait. Instead, the whole process took less than two months from the time I submitted the paperwork!

Something has changed over at the CDRH, in a good way. Whatever it is, I'm psyched for them and for us. If you have been delaying doing your paperwork, it seems like 2011 is a good time to get it in.

Mike

[allthatwhichis]

VERY NICE! I got my accession number yesterday; hopefully my varience is right around the corner.

[dsli_jon]

Hey Sir Mike!

The FDA just approved my variance.

Congrats, m8! Curious, this must be for your Projector, correct? Unless you also listed other 'already-Certified' projectors (ie: MoboLazer, etc...) in your Show-performance Var, which would not be issued until your Projector, itself, was-approved (if the only-one on-there...) If-so, good job, man! I think you just might have set the record for speediest Projector-approval - 2 mo's!

Anyhoo, Congrats, and kudos for setting a great-example on PL / proving it 'can be done'... will be keen to see 'results', now...
cheers...
j

[mophead]

Good Job!!

I now have a semi renewed faith. Hopefully the one I will be submitting here shortly will receive the same speedy service.

[JohnYayas]

Wow. This is good news to hear. I may get a variance for mine if the good news continues.