Sorry for being late to jump in on this thread (been busy!), but I did want to clear up one misconception:
Actually, there is a very clear line. The FDA derives it's authority from it's congressional charter, which authorizes it to regulate COMMERCE. So as long as the laser product is (or will be) involved in COMMERCE in some fasion, then CDRH regulations apply.
So - build a projector and use it in your basement? No variance required.
Build a projector and use it for a halloween display in your garage for the neighborhood kids? No variance required.
Build a projector and use it in a nightclub? BOOM! Commerce is involved and now you need a variance for the show *and* you need a manufacturer's variance in order to certify that the projector you built is compliant with all federal regulations. Note that even if you are doing the actual laser show for free, because it is a place of business and it is reasonable to expect that people will come to see the show (and buy drinks in the process), commerce is still indirectly involved and CDRH rules must be followed.
Yup. As stated above, no variance is required to do this.my perspective is that if you are in your own home for your own private enjoyment, that does note require a variance.
HOWEVER, if you *purchase* the projector, then you have to have a variance, since the *purchase* falls under the commerce clause. You can only avoid this if you build the projector from scratch yourself. Even if you buy it with the intention of only using it in your house, the fact that you bought it means you need the variance. (Though you could let it expire once you have the projector in your hands.)
Note also that importing a projector from China (or any other country) requires you to fill out a customs declaration form (FDA form 2877) which specifies the plan for either bringing the projector into compliance (under a manufacturer's variance), sending it back out of the country, or destroying it. Failing to submit this paperwork can result in your projector being seized by customs officials at the border.
100% agree. Even if commerce isn't involved, the local authorities (especially your local fire chief) can make your life hell if you don't play by the rules. Having your variance is the first step in demonstrating that you know what you are doing.As soon as you start doing shows outside your home, I would suggest having a variance in place.
Technically at a church there is no commerce (churches are tax-exempt), and I know several operators who do church shows without a variance, despite the fact that this is not recommended. I've spoken directly with the CDRH about this exact issue in the past, and while they *really* didn't want to admit it, eventually they did go on record stating that a church show would be out of their jurisdiction.You could do a show say at a worship service for free, and that would still require a variance.
Even so, it's a bad idea. You can still be sued, and not having a variance will make you look like an idiot in court. But it's not legally required in this case.
This is perhaps the best advice in this thread. A variance is not something to be fearful of. It's a tool that helps you perform your shows safer. It also demonstrates a basic knowledge of laser safety, and that always looks good.Use your common sense, and just plan to get one. there's no reason not to, its free, and you'll learn a TON in doing to the work to get it.
Adam