FDA offical inspect our variance and accession number laser projector

[DSOTM1973]

Well this is going to be a hassle. I've had my pj from them for about a month and this already? Rather disappointing I guess...

[norty303]

Wait and see what the hassle might be before getting all down about it. It could be a trivial fix. It sounds like a change of component that is NO instead of NC (or similar sort of thing)

[ablelaser01]

Well this is going to be a hassle. I've had my pj from them for about a month and this already? Rather disappointing I guess...

Hi, Did you buy from us directly?
May I have your name or e-mail?
And then we check whether your laser is 100% FDA standards or not.
Your e-mail is also welcomed.
info@able-laser.com
We will reply you in time.

[DanG]

I have always supported every company for wanting to do things the right way, and Able specifically for going through the process to get the variance. This is very good. However, I must point out three things:

1) There is no such thing as an FDA approved projector. This may be a language issue, but it is an important one. FDA does not approve projectors.

2) A recall cannot be handled by sending parts because the integration of the parts needs to be followed by testing to determine compliance by the manufacturer. Again I respect Able's decision to make their product compliant but people can't just add their own interlocks and self-certify on behalf of a manufacturer. That is a major safety feature and is required to be corrected by the factory to ensure that the projector will fail safe under any single fault condition. We could never make end users responsible for this no matter how competent they are.

3) This issue means only one of two things: either the product report submitted for the variance was incorrect or the manufacturing changed from the product report. In Able's defense, this is extremely complicated to manage over years and many models. Things do happen. However, it underscores the notion that users need to actually check their laser products to determine compliance as best as they are able so that they do not end up using non-compliant equipment for months or years potentially subjecting themselves to liabilities.

I appreciate companies like Able trying to do things the right way, this is very good, but I reiterate that the manufacturer is responsible for correcting safety related defects. This causes a lot of international shipping and customs issues, but that's just the way it goes.

[ablelaser01]

I have always supported every company for wanting to do things the right way, and Able specifically for going through the process to get the variance. This is very good. However, I must point out three things:

1) There is no such thing as an FDA approved projector. This may be a language issue, but it is an important one. FDA does not approve projectors.

2) A recall cannot be handled by sending parts because the integration of the parts needs to be followed by testing to determine compliance by the manufacturer. Again I respect Able's decision to make their product compliant but people can't just add their own interlocks and self-certify on behalf of a manufacturer. That is a major safety feature and is required to be corrected by the factory to ensure that the projector will fail safe under any single fault condition. We could never make end users responsible for this no matter how competent they are.

3) This issue means only one of two things: either the product report submitted for the variance was incorrect or the manufacturing changed from the product report. In Able's defense, this is extremely complicated to manage over years and many models. Things do happen. However, it underscores the notion that users need to actually check their laser products to determine compliance as best as they are able so that they do not end up using non-compliant equipment for months or years potentially subjecting themselves to liabilities.

I appreciate companies like Able trying to do things the right way, this is very good, but I reiterate that the manufacturer is responsible for correcting safety related defects. This causes a lot of international shipping and customs issues, but that's just the way it goes.

Hi ,friend, thank you for sharing so much and important info with us ,it seem that you know FDA very well .

You are right,the manufacturer is responsible for correcting safety ,we always if there any help to correct the interlock ,just send it back to us ,and we will fix it ,it is not a big deal ,but most of our customers are very professional ,they can fix it by themselves according to our instructions.

But I am confused the words you said FDA does not approve projectors? Projector is listed as a possible dangerous product when imported to USA ,and projector is also scope of jurisdiction of FDA ,projectors is one items of jurisdiction of FDA.Officials of FDA visited our factory three times ,to help us to meet the requirement of FDA,if you guys don't believe it ,this is Emir's email,Official of FDA ,emir.galevi@fda.hhs.gov,you can ask him for the things we said is true or not.

[buffo]

,but most of our customers are very professional ,they can fix it by themselves according to our instructions.

Dan's point is that, from a LEGAL standpoint, this is not acceptable for projectors sold here in the USA.

Any change to the safety system of a certified projector must be RE-CERTIFIED through quality-control testing BY THE MANUFACTURER. Since you are the manufacturer, you must perform these quality-control tests, and you must maintain the records that show the tests were performed satisfactorily. It is not OK for the customer to do this, even if they have the knowledge and experience to do so.

Note that this is a requirement of your manufacturer's variance issued by the CDRH.

I am confused the words you said FDA does not approve projectors?

Again, Dan is correct. The FDA does not certify the projector. You certify the projector under your own manufacturer's variance.

Here's how that process works: The FDA receives a product report from the manufacturer. The product report details the features of the projector, the safety systems, and perhaps most importantly, the quality control tests that you, the manufacturer, will perform on the projectors to ensure that they meed the requirements.

The FDA (or more accurately, the CDRH) then examines the product report to ensure that your process will result in a projector that will be compliant. If they are satisfied that the product report is adequate, they accept your product report. But this does not certify the projector. YOU, the MANUFACTURER, are the one who does the certification, under the authority provided to you by the CDRH once they have accepted your product report.

I suspect that you have contracted with a consultant to assist you in preparing your product report and in obtaining your manufacturer's variance. As such, it's possible that the consultant didn't explain all the details of the process to you. But this is really how it works. The FDA (or the CDRH) has *NEVER* certified a laser projector - ever. They only approve or reject product reports, which can describe a whole family of projectors. More importantly though: what is actually getting approved is the PROCESS of building and testing a projector (or a family of projectors), and not the actual projector itself.

Basically, the product report is a manufacturer's way of showing the CDRH that they are competent enough to certify their products as being compliant. And the CDRH merely says "Yes, you are competent enough to do this", or "No, we don't think you have provided enough information for us to allow you to do this, please supply extra information related to the following requirements...." Also, following an inspection, they (the CDRH) can require manufacturer's to change their process if they discover a problem. (This is undoubtedly what happened to your company recently.)

Finally, please understand that Dan operates a company that has sold thousands of legal, certified projectors, and this company is located in the same city as the CDRH headquarters. He is also the chairman of the ILDA committee on laser projector regulation reform. Thus, he is more than qualified to comment on matters of projector certification. You really should be listening very closely to what he has to say.

Adam

[DanG]

Hi Able,

Thanks for the note. And thanks also to Adam for the reply.

Please understand, it is not that I do not believe you. In fact, I think you are being very forthcoming and truthful which is good. I simply think that there is a misunderstanding which Adam has described quite well.

FDA does not approve projectors. They do not approve Able projectors, or X-Laser projectors, or Arctos projectors or any projectors. What they do accept is the product report which specifies how a projector will be built, and the quality assurance program which the manufacturer puts in place to ensure that the projectors are built according to the certification. That's all, just as Adam says.

It is for this reason that end users (customers) are not able to make safety related repairs. Even if they are highly skilled, they cannot take responsibility for your quality control process. That is something only the manufacturer can do and why every single X-Laser must be returned to us for service and recertification. It is possible, in theory, to have external folks do service on your products. But, as we understand that process would need to be approved by FDA, records would need to be kept, training would need to be performed and so forth. Its is not as simple as just sending someone a part and asking them to splice a few wires.

I would suggest contacting FDA with your corrective action plan and letting them advise you about the best way to proceed. After all, they have the final say in such matters and may decide to make things easier. Who knows? Anyway, kudos on being one of the few trying to do things the right way. Good for you.

I wish you luck in this process of getting the non-compliant fixtures back and moving forward.