CDRH Compliance?? Is it possible?

[Misebeam]

I have read so many threads about what a nightmare it is to obtain a CDRH cert for a home built projector. has anyone out there ever actually achieve a CDRH cert?, or is it all still buried under piles of paper work. How can I get started?

Thanks for input!

[wes]

don't know if this is true,but i've heard it said it is easier add home builts to a variance you already hold.
maybe get a cheapo projector that is compliant and apply for a variance for that.

[nono shen]

I agree with you. There are so many papers and files to read , so boring and dry, made me headache. Your experience made me remembered when I passed the certification beforetime.

That time, our company need get FDA certification of our laser products, I am chief functionary, all the process are completed by myself. Including meeting FDA officer. they are so kind, that's the only thing made me feel well and conciliative.They help me a lot about those dry paper and form.

[Pangolin]

If you are not going to be doing:

a) Truly public performances, or;
b) Performances for a fee

then you probably do not need to get a variance. HOWEVER, the variance process may not be as difficult as you think, especially since CDRH now has software to help in this regard. Basically, you go through the software process, sort of like Turbo Tax. It asks you questions. You then use these questions as a clue as what your projector will need in order to comply (again, sort of like Turbo Tax asking you financial questions) and you answer the questions, hopefully correctly (like Turbo Tax). If you answer the questions correctly, then in some period of time (hopefully 4 weeks or less), then you get a variance. If not, then you get a visit from the IRS, I mean CDRH

Best regards,

William Benner

PS: Just kidding about the visit... You would get a letter, explaining why your application was not accepted, and then you would use that information to update your application (sort of like Turbo Tax, but without the additional penalties and interest...)

[buffo]

Hi Bill;

I'm intrigued by this "Turbo Tax for Variances" software. I searched around on the CDRH site but couldn't find any mention of it. Is it a web-based form on their site that you fill out, or is it a package that you download and run on your own computer which spits out a report that you mail in?

If you have a link to the software, I'd really like to have a look at it. I'm seriously contemplating applying for a variance. The folks at the auditorium in Newton, NC are interested in having us back for their community unity day festival early next year. It wouldn't be a for-profit show, but it *would* be open to the general public. I told Reggie that I'd consider it, but there's no way I'm going to do it without a variance!

Any info you can provide would be greatly appreciated!

Adam

[VJ AIWAZ]

http://www.fda.gov/cdrh/cesub/radhealth.html

[buffo]

Cool! Thanks VJ!

Adam

[Misebeam]

Wow,
Thanks Bill, for theusefull information. I am planning on doing public light shows for $$, and am in need for a variance. I have been all over the CDRH site, and have tried to call their phone to request the cfr 21 1040.11 (c) packet, but it always goes into voicemail. Thanks for the info!

Okay ready for the cheatsheets.... is there a CDRH for dummies... just kidding

[Misebeam]

Okay, it has begun... I started reading the delightful 26 pages of 21 CFR 1040.11(c). WOW, it's right up there with have teeth extracted I just finished purchasing of my safety interlock switches, key switch, beam stops (shutter), and indicators… WoW Now I have to get the labels printed out, and start putting all info into the new CeSub eSubmitter with pictures. Doesn’t look to bad to complete, just a bit tidies.

Let me know if anyone has any tips I need to follow! (other than a double espresso to keep me awake while reading the document