CDRH Annual Reports due by September 1st!

[buffo]

Just a reminder for everyone in the US who currently holds a laser light show variance with the CDRH... You need to file your annual report by September 1st if you want to keep your variance.

Here's a link to form FDA 3636, which includes instructions on how to fill it out. (It's 17 pages long, but you only need to print out pages 11,13,15, and 17.) Also, if you aren't producing any laser products (eg: projectors), then you don't need to fill out the middle two pages. (It's all explained in the instructions.)

Adam

[Bradfo69]

Humm... not the way I read it. Page 13 is where you list the number of shows, etc. I really think it's bizzare that:

The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide. This guide will assist manufacturers¹ of electronic products which emit radiation in providing adequate reporting of radiation safety testing and compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify Reporting and Notification requirements²,³.

This form is supposed to be for the manufacturer of electronic products which emit radiation. That, to me... is like an X-Laser or CT Lasers. I don't think of myself as manufacturing an electronic product. I guess CDRH does but, it's just dumb. Everybody on here knows I don't know shit about electronics! LOL

Also... on 3.2 - What do you think I should put under Projector or Show Family Designation? Would I say "wedding", "prom", Sweet 16" ??

[dsli_jon]

...I don't think of myself as manufacturing an electronic product. I guess CDRH does but...

Ayeup.. Remember Page 18 (PDF-Page 19) of this lil' puppy?: http://www.fda.gov/downloads/Medical.../UCM119257.pdf ...You be a 'Manufacturerer' '...even if the act of manufacture is simply setting up a show in a particular location, or changing a general-purpose laser to light show use'.. etc..

..And, the 'rationale' for this is sound.. Putting that onus on anyone who puts-on a public-sho, 'as a manufacturer' - even for those who are 'just' pj-dealers or distributors, even - ensures that the 'path of safety education' / best-practices, is (hopefully..) passed on.. Ya know, kinda like sex ed for your kids..

..What anybody does with it, from there, well.. Some are responsible / self-governing / don't hurt people / still make awesome shows, and others, well... 'Epic Failsers' comes to mind..

Also... on 3.2 - What do you think I should put under Projector or Show Family Designation? Would I say "wedding", "prom", Sweet 16" ??

Just use the Last Name of the Bride for the 'Family Designation', her younger sister's cel in the 'Accession Number' box ..'Permanent or Touring', depends on how drunk they were..
..'Class', well... during the 'garter ritual', were panties-observed or not? ..and, well.. there ya go..

..OK, so off the sauce:

Accession#, that of those you registered-with / used in your shows during the said-year; 'Projector', well, ie: 'Mobolazer ML-10', etc, etc.., matching the # in the Acc.-box; 'Perm or Touring' - in your case, Permanent (unless you did a remote-gig.. and 'Lasing Media' (Diode, Argon, ArKr, etc etc) and 'No. of Shows Performed, well.. You get it..

However, even-though we don't have to file the indie-show Reports, anymore, we're still supposed to be *making* them, for all shows, and - that's where the 'Model No. or Name of Show' comes-in, in Part 5... You're (supposed-to.. have those docs - for each show - made, and cataloged / stored at yer facility..

..So, for example, you'd have a line called 'Booyah Family Wedding Sho' / Number Produced: 1, etc, etc.. If you did a 'conference' (where there might be 'multiple-days' of shows..) it could be, ie: 'Richardson Metals Sales Meeting', '4 shows' (Days..), etc, etc... So, I'm sure you can 'extrapolate'...

That's what I've always done / has never been 'rejected' or hiccuped, so.. fwiw..

ttys..
j

PS - Addys, and other info-bank, are all still here.. http://www.photonlexicon.com/wiki/index.php?title=CDRH ..We Love You MotherWiki!...

[buffo]

Page 13 is where you list the number of shows, etc.

It also says if you don't have any products, you only need to prepare the first and last page.

Admittedly, I interpreted it in the strictest possible sense, so I also listed my shows on the middle pages and ended up filing all 4 pages, but I wrote "no tangible products - only laser show performances" pretty much everywhere on the forum.

I don't think of myself as manufacturing an electronic product.

Yeah, I agree, which is why I wrote "no tangible products"...

On 3.2 - What do you think I should put under Projector or Show Family Designation? Would I say "wedding", "prom", Sweet 16" ??

That's what I did. For example, I did a 4th of July show, so I put "Patriotic 4th of July graphics show" and listed the date and the name of the client...

Adam

[Bradfo69]

Here's a question... does X-Laser offer guidance for this for all the DJ's that have their EZ-Variance Kit? I mean... if WE'RE (who kinda have a clue) interpreting it in various ways, what the heck is "DJ Jazzy Jimmy" doing?

[swamidog]

"DJ Jazzy Jimmy" is most likely doing illegal shows.

Here's a question... does X-Laser offer guidance for this for all the DJ's that have their EZ-Variance Kit? I mean... if WE'RE (who kinda have a clue) interpreting it in various ways, what the heck is "DJ Jazzy Jimmy" doing?

[Bradfo69]

Ahh but... if he bought an X-Laser from an X-Laser dealer, then he would have gotten an EZ Variance kit and should know a little more than the average DJ.

However... just because the variance process was made easy, doesn't necessarily mean the annual report process necessary to KEEP said variance is "EZ". I'm just wondering if X-Laser has a posotion or method to make that EZ as well. Otherwise you have a bunch of variance holders who all own X-Laser products trying to fill this form out. And, if we who have some knowledge of the process are not entirely sure of the best way to do it, DJ Jazzy Jimmy will likely have even less of a clue. That's all.



Edit - Kind of make me wonder about all the X-Lasers sold over the past several years and if there are a bunch of people running around thinking they're legal and doing things on what are now expired variances. (If they didn't do the report.)

[swamidog]

true.. sorry i missed that. i don't want to give the impression the x-laser is skirting the law.

Ahh but... if he bought an X-Laser from an X-Laser dealer, then he would have gotten an EZ Variance kit and should know a little more than the average DJ.

However... just because the variance process was made easy, doesn't necessarily mean the annual report process necessary to KEEP said variance is "EZ". I'm just wondering if X-Laser has a posotion or method to make that EZ as well. Otherwise you have a bunch of variance holders who all own X-Laser products trying to fill this form out. And, if we who have some knowledge of the process are not entirely sure of the best way to do it, DJ Jazzy Jimmy will likely have even less of a clue. That's all.



Edit - Kind of make me wonder about all the X-Lasers sold over the past several years and if there are a bunch of people running around thinking they're legal and doing things on what are now expired variances. (If they didn't do the report.)

[buffo]

You may want to check with Dan Goldsmith, but it's my understanding that they have a standardized form that they offer to all their customers. (He offered it to me last year, so I assume any X-laser dealer or customer could get a copy.) It's a simplified version of the CDRH form I linked to above, and it has columns for the types of shows you performed during the year and the number of each. At the bottom is the section about recalls and safety directives.

It's pretty clean, and I considered using it last year, but in the end I decided to just go with the standard CDRH form and just hand-write everything in.

Adam

[Stuka]

Here's a question... does X-Laser offer guidance for this for all the DJ's that have their EZ-Variance Kit? I mean... if WE'RE (who kinda have a clue) interpreting it in various ways, what the heck is "DJ Jazzy Jimmy" doing?

Yes, the EZ variance kit includes "fill in the blank" annual forms as part of the documentation packet.
Of course, that would require the variance holder to actually take a few minutes to review and fill out the forms, which might be beyond the ability of some of the "dj's" we read about on here sometimes...

Randy