X-Laser's New Variance Process

[DanG]

I was talking about a product report, not a variance.

[ElektroFreak]

dont worry, your not alone, thats why I just gave in and bought the OSLS enclosure... its actually really nice



from my understanding somewhere, something, says that the FDA cannot impede commerce or something like that... so after waiting a certain magical period of time (I have heard 90 days several times) you can do shows with your accession number even though you have not received an actual variance back from the CDRH

Here we go again .. some knowledgeable folks say one thing, others say another. These differences exist even between people who do the same thing professionally.. Here's what I have to say: If there is a black market for shows (and there is) it exists because of this kind of crap. If you (the gov't OR the laser show guys who are pissed because some people are circumventing the law and cutting into their profits) want people to comply, the LEAST that can be done to that end is to make this stuff CLEAR and CONCISE. This jumbled mess of opinions about just what is ok and what isn't is ridiculous child's play and should be treated as such. There is no reason to take any of it seriously as far as I'm concerned. It's all just a big fucking joke. It depends on the person whether they want to waste their valuable time and effort dealing with it or not.. At this point, speaking only for myself, I don't fault anyone for NOT participating in this farce.

@Flecom: If the OSLS case wasn't bloody awesome I'd be in my car looking for someone's teeth as payment for such a rip-off. I already feel that they're gouging people.. I just really have no need for all that space or an optical table. I'm interested in making my own compact full-color systems, along the same vein as some of the newer RGB lasersystems units in terms of dimensions.. not gonna happen in an OSLS case.

[norty303]

I don't know how it is over there, but over here, government departments have to ensure that anything published meets plain english requirements. I would guess if you could prove that you'd followed the letter of the documentation, but tripped up due to poor wording/detailing on their part, you'd have a defense.

[mixedgas]

Electrofreak, the only time some one looks at your hardware is 1. There was a reported incident. 2. Many of the regional EOS liked to, in the past, visit every one who got a variance in their area at least once, during a show, or at your home base, for a simple, quick, inspection, usually lasting the duration of a cup or two of coffee. If the EOS did not find any errors, they get on the road and head for their next inspection, which is unlikely to be another laser. They hand you the executive branch version of a warrant, which you sign and initial and the inspection starts. Mainly they want to read your QC paperwork and see if all the safety features are working. Unless its a glaring hazard, the worse that happens is you end up submitting a written response to how you corrected the problem.

The EOS are not just laser specific, they have a lot of other installations they visit. The EOS takes guidance from CDRH, but is working for a different arm of the FDA, called ORA, and the one I have met has other duties as well as lasers. They will try to help you if you call them with a question, Our local one answers his phone and emails, or gets back to you within a day or two. If I need to reach him in a hurry, and I have once, there is a secretary. They are more interested in bulk manufacturing, and laser visits probably only occur if they have other travels in the area. Unless your really screwing up, or have a public install some place, they even call ahead for a appointment.

In fact, if you wish, your EOS is there to answer questions, you can ask them to be pre-emptive and help you out, ie ask design and procedure questions. They may not be up to date on DCs latest and greatest, but they know the basics.

* EOS = Electro-optical specialist, which means they can spell the word laser and read a book of requirements, and are good with people and travel. Odds are they will not even bring a power meter or other instruments. They have a badge, but not a gun.

At least that is my experience.

So no expensive "certification test" on the hardware.

Steve

** In defense of the 1500$ certified box, there are a lot of people who do not even own a dremel tool, and those who would not even know where to begin on how to make a metal box in a shop. Consider OSLS's position. They have to support the box and the buyer of the box. If the buyer of the box is a blooming idiot, they end up stuffing the box anyways. So the 1500$ is insurance in case they have to spend time supporting the product. It is a very nice, well built, very capable box,very big box. Consider the fact that it probably costs 500$ to make the box. The one I have seen has a huge optical breadboard in the base. Its a quality box, and built like a Abrams tank.

Steve

[ElektroFreak]

good to know... until someone else disagrees and gives their $.02.. no offense to you Steve, but that's how it's been going so far.

This EOS.. are they contacted via my local FDA/CDRH office?

[DanG]

If you tell me where you are I would be happy to pass along your local EOS contact info. But no disagreement from me on Steve's points.

[ElektroFreak]

I live and would be working primarily in the St. Louis metro area..

And I really appreciate the time and effort everyone in this thread has put into helping me get this all down. I've been frustrated by the cryptic, murky nature of all this for so long that it's got me pretty raw on the whole concept. None of my frustration is directed at any of the folks trying to help me.. Thanks, really.

[DanG]

Your EOS is Don Leesburg - 210-698-7372 voice, 214-253-4960 fax.

He is actually headquartered in the FDA field office in Dallas.

FDA (HFR-SW19)
4040 N. Central Expressway, Suite 900
Dallas, TX 75204

Nice guy. Very deliberate and reasonable. He will be of great help I think.

[ElektroFreak]

Many many thanks for that info X-Laser..

[Phredy1]

Once you submit your paperwork, and get you ack letter and/or accession # you're good to go.

-Marc

In who's lifetime? This is the same CDRH the variance paperwork goes to....??

I got an approval just a few weeks ago and we could not sell the unit until we had that in hand.

Seriously you actually got CDRH to approve something? Holy shit, I'm in shock. I see the problem now. You are overworking CDRH and our paperwork is in the ignore pile until yours gets done..... LOL