The FDA approved my variance application!!

[blowfly]

Oh wait, they just sent a docket number. The docket number ended in /VAR. I assume I'll get another docket for the product and show reports.

I'm still jazzed though, this is progress! I'm on my way to being a full fledged laser operator. Thanks again to all the swell folks who helped me with the projector and the paper work.

[mixedgas]

Oh wait, they just sent a docket number. The docket number ended in /VAR. I assume I'll get another docket for the product and show reports.

I'm still jazzed though, this is progress! I'm on my way to being a full fledged laser operator. Thanks again to all the swell folks who helped me with the projector and the paper work.

I "think" UNDER LASER NOTICE 50 YOU CAN START DOING SHOWS!
You do need to confirm that.

Steve

[blowfly]

I "think" UNDER LASER NOTICE 50 YOU CAN START DOING SHOWS!
You do need to confirm that.

Steve

That would be sweet! I'll look into it.

[edison]

Concratulations!!!!! Very happy for you blowfly!!!!! Did they have any comment on the case?

[allthatwhichis]

That's awesome; about how long ago did you send it in?

[blowfly]

That's awesome; about how long ago did you send it in?

Sent it in only two weeks ago! No real feedback yet, I'm sure it will take a while for them to get around to reading it.

[allthatwhichis]

Sent it in only two weeks ago! No real feedback yet, I'm sure it will take a while for them to get around to reading it.

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...

[dsli_jon]

Hey Sir Mike -

I "think" UNDER LASER NOTICE 50 YOU CAN START DOING SHOWS!

"Letter of the Law": no you can't, untill you actually *get* your approved Variance letter... this was re-iterated recently, and is (one-of.. ) the crux(es) of the 'beef' that practically the entire laser-sho industry has with the CDRH... People not getting approvals for 1+ year is actually *increasing* 'illegal' operators / fx, not curbing them... (...cuz people say sqrü this, man, I gotta eat!)

'Spirit of the Law': If you're using a known-Certified Projector, and you have all your other 'ducks in a row', many to most successfully-filed Ops (like yourself) *are* going-ahead and putting rubber to the road... This is not an 'official endorsement' for such-action, mind-you but hey - as they say, 'ya gotta do what ya gotta do'....
let your walle... I mean your conscience be your-guide...

But if you ring-up the CDRH and ask them, they'll say "No, you must wait"... Then-again, I suppose it might depend on who you get on the phone as some have experienced...

Here's to yer Approval Letter!

Kwak!

cheers..
j

[MechEng3]

Not to be a buzz kill...........I wouldn't hold my breath......had my letter of receipts and numbers for over a year now. Still in a holding pattern. And I did speak with D. Smith on several calls and e-mails. The usual reply is "It is being reviewed". I have just forgot about it mostly. The way things are with the economy and all....I would be surprised to hear from them again. Happy for your progress though!

[norty303]

If i was in your position (which thankfully, I'm not!) I'd just get out there and do it. IF they don't have the time to process the applications, they probably don't have time to investigate you either - and I guess if all your paperwork is in order anyway, there'd be some fight over whether you were operating inappropriately anyway.