I will pay you $100

[flecom]

I am going to need some Captain to get much further with this I think.

reading your post gave me a migraine I shit you not

the irony of all this if you never do a show report/variance the CDRH wont know your doing a show so they cant come inspect you - not that I would ever do this or advise anyone else to do this

[buffo]

Really good discussion going on here. Thanks to Dan for starting the topic. (And sorry I'm so late; I'm still playing catch-up!)

If a manufacturer has to submit a product report before they can have approval to introduce the product into commerce and,

If a manufacturer has to obtain a manufacturer's variance before the product can be made and,

If a user has to obtain a variance to use the product once it has already been product reported,

What would the purpose or effect of having a device specific variance be?

I thought a device variance was needed to verify that anything listed in the laser product report (note: laser product report is completed and filed *after* the unit is assembled and tested) that differs from 21 CFR 1040 is properly documented and approved by the CDRH.?.

So let's say you build a class IV laser projector that uses all solid-state lasers, and you choose to omit the safety shutter because your interlock system completely shuts down power to the laser(s), so there is no chance of any stray light coming out of the projector. It only produces light when it's supposed to be displaying an image. This would require a variance, since 21 CFR 1040 states that all class IV laser demonstration products will have a shutter. (For the sake of argument I'm omitting the more convenient route of certifying using IEC regs as allowed under laser notice 50, though admittedly that would also require a variance - if only to specify that you're certifying under the terms of laser notice 50.)

Allowing you to "vary" from 21 CFR 1040 is not a sufficient answer IMHO because permission to do that would either have already been granted, or would have to be granted through one or more of the mechanisms above.

It is my understanding that no permission is needed to vary from 21 CFR 1040 until you intend to introduce the product into commerce. At that point, you need to file for the variance. (Or, if your product is 100% compliant, then you still need to at least file a laser product report.)

I also want to make sure that we draw a distinction here between being given permission to use or make a specific device as is established by the clause that Arc copied: "Upon application by a manufacturer, the Director of CDRH may grant a variance for a product"- and permission being given to the device itself... to I don't know... exist.

The laser product report allows you to enter it into commerce. A variance allows an otherwise non-compliant product to be entered into commerce. As far as I'm aware, there is no paperwork requirement for the device to "exist". If you aren't selling it or using it in a show, you can build whatever death-ray device you want in the confines of your own shop. You can even use it to fry mosquitoes in your bathroom if you want. But before you sell it or use it for a show, you need paperwork on it. That's my understanding, anyway...

Importing laser products into the US is a completely different matter, mind you. But if we ignore the importing problem, then I don't see where a manufacturer needs to file any paperwork for the things they assemble, at least until they decide to enter them into commerce.

To me there is a difference - in fact a BIG difference - between a device being being built and certified under a MFG variance and a variance being granted to a device irrespective of the process by which it was made which would be the case if someone only had to fill out FDA3147 and not a product report.

I'm not exactly sure I follow the line of reasoning here.?. Is someone claiming that they can build a projector completely from scratch, enter it into commerce, and *not* have to file a laser product report?

I understand that the CDRH is allowing people to start with a pre-certified projector (or even a projector housing, ala the LT-1000) and then just reference the accession number for that projector on their show variance application, but that's not really the same thing.

In fact the sticker that is required to go on top of the thing is required to say something to the effect of "...device complies with' blah blah 'except for deviations pursuant to manufacturer's variance [variance number here].' No where that I know of are you ever asked for a **device's** variance number.

Isn't the manufacturer's variance where any deviations from 21 CFR 1040 would be noted? (Well, there and in the laser product report of course.)

As for the device's number, I'd assume it would be the accession number for the product report that they'd actually reference, unless the product was granted a special variance for non-compliance with some part of 21 CFR 1040 (as in the shutter example above)...

I am going to need some Captain to get much further with this I think.

Put it in the freezer; it gets really thick! (I love me some frozen Captain Morgan's and pineapple juice...)

Adam

[flecom]

[QUOTE=buffo;166059Put it in the freezer; it gets really thick! (I love me some frozen Captain Morgan's and pineapple juice...)[/QUOTE]

grey goose gets pretty thick when you put it in the freezer too... its awesome

[DjHeadie]

grey goose gets pretty thick when you put it in the freezer too... its awesome

before you started building your custom bar set i was a few steps ahead of you... ill take pics soon

but i have an old, 70's mini freezer, brushed aluminum, proper fallout looking, constantly keeping a bottle of the goose, and six of these

got quite a few random labware type glassware as well, purely for bar novelty, but id rateher not pollute this thread with it.

grey goose + energy drink will always be my stay up late drink, whether im running lasers, djing or just partying hah.