Getting a projector variance from the CDRH...

[buffo]

Hey guys...

I was talking with Paul (Clandestiny) the other day, and we started talking about the problems involved in getting a home-made projector approved for a variance by the CDRH.

Paul said that he took the easy road by purchasing a pre-made projector that already had a variance from the CDRH. He siad that doing so saved him a ton of hassle vs trying to get a home-made projector approved. (Which makes sense, I suppose, since the CDRH is going to hold you to the same standards for your projector that they expect Medical laser Manufacturers to adhere to.)

Anyway, I was wondering what some of the other laserists here have to say about their experiences with the CDRH, particularily with regard to getting a projector variance approved. Has anyone here actually gotten a home-made projector varianced, and if so, was it the first variance you tried to get, or was it only attempted after you had purchased several other pre-made projectors that came with a variance?

Adam

[MechEng3]

It is shal we say pending......I have spoken with several of the so called people in charge and finally gotten hold of 2 persons of intrest. They seem to want to help , but are adhering to the rules....all the way. I intend to comply. From here it is looking like a flurry of paperwork, a few calculations , and proof that the unit meets criteria set forth by their rules. Not that bad ....but one must be patient with them. I am having good open talks with them and all is going well so far in the first stages of describing the unit and it's safety features. I will release more later as things get resolved to a concrete final stage.