Reporting Illegal Lasers/Laser shows

[buffo]

Send the new picture in as further evidence. The CDRH moves slowly, but when they move, people take notice. They just posted a letter where they went after Laserworld (yet again!) for violations. So they do listen to what people sent them.

Adam

[mixedgas]

Example of a corrective action notice:

http://www.accessdata.fda.gov/script....cfm?id=111195

If you dont think this is painful, imagine the cost of recalling, rebuilding, relabeling, and re-shipping nearly every projector in the US at no cost to the customer.

Steve

[drm916]

Send the new picture in as further evidence. The CDRH moves slowly, but when they move, people take notice. They just posted a letter where they went after Laserworld (yet again!) for violations. So they do listen to what people sent them.

Adam

What happened? I wanna read that. I am nosey. lol

never mind.. Think I found it.

http://www.fda.gov/iceci/enforcement.../ucm438367.htm

[Laser Wizardry]

" 15 characters"

[VibrationsOfDoom]

The FUNNIEST part of this letter? The part where he states that you're not supposed to be able to open the case without "special tools..."

So what "special tools" did the FDA have?? This is priceless...

"Although your product report asserts that “special tools” are required to open the protective enclosure, FDA was able to complete this task by removing typical Phillips screws with a regular Phillips screwdriver."

[flecom]

The FUNNIEST part of this letter? The part where he states that you're not supposed to be able to open the case without "special tools..."

So what "special tools" did the FDA have?? This is priceless...

"Although your product report asserts that “special tools” are required to open the protective enclosure, FDA was able to complete this task by removing typical Phillips screws with a regular Phillips screwdriver."

interesting, from the xlaser variance talks their interpretation was that anything that was not a thumb screw required a "special tool" so even a Phillips would be ok

if the CDRH is saying that a phillips is not ok that would be bad for everyone seeing as most "compliant" projectors just regular phillips screws

[JD3]

you only have to have "special tools" screws if the projector is not intended for end user service, AND does not have case interlocks.

You can have just thumbscrews if you have the proper case interlocks, and warning labels.

[buffo]

from the xlaser variance talks their interpretation was that anything that was not a thumb screw required a "special tool" so even a Phillips would be ok

I think you missed the point of that statement. It's not their (the CDRH's) interpretation, but rather yours (as in the person writing the product report) that matters. So long as you are consistent in what you say (within reason), you are OK.

This is why there are certified class-4 laser projectors on the market right now that do not have a "start" button. Several companies have successfully argued that the rising edge of the kill-switch signal as the button is reset constitutes a "RUN" signal. Personally I disagree with this position, as I believe it violates the spirit, if not the letter of the law, but the CDRH has allowed it.

most "compliant" projectors just use regular phillips screws

Yup. And most compliant projectors also do not have case intrusion interlocks. It's all in how you write the report. (See below)

you only have to have "special tools" screws if the projector is not intended for end user service, AND does not have case interlocks.

This is incorrect, although it is a common misconception.

I have a product report on file with the CDRH that covers a line of projectors which do not have case interlocks. Furthermore, all the projectors use standard Phillips screws. The CDRH has not said 1 word about it. (The report was filed last summer.)

The difference is that my product report specifically states that the end user is NOT ALLOWED to open the case. The owner's manual states this as well. All activities that would require opening the projector housing (such as cleaning/re-aligning optics or tuning scanners) are defined in the product report (and the owner's manual) as SERVICE activities that can only be performed by the manufacturer (me) under controlled conditions.

Likewise, the projector is required to have several dedicated warning labels (3, in fact) that do nothing but warn the user of the fact that the case is not interlocked and that opening the case may expose a person to dangerous levels of light. There is even a detailed quality control procedure that must be followed for each projector certified that checks and double-checks for the presence of these labels.

This is not a unique approach. Many laser projector manufacturers here in the US follow the exact same steps I did. The key is to be 100% consistent in all of your writings in the product report. (Having the proper language on the labels, having them in the right locations, and having a good QA/QC program is another piece of the puzzle.)

Note that as far as the CDRH is concerned, there are 4 main task categories to consider: operation, maintenance, service, and repair. They consider the first two categories to be things that will be done by the end user, while the other two are done by the manufacturer, and your product report must clearly state how you intend to keep people safe when doing work in all 4 categories.

But the key point is that the manufacturer can dictate which tasks fall into each category, and it is far easier to ensure the safety of the manufacturer vs the end user, so it makes sense to relegate anything that requires entry to the case to the Service category and let the manufacturer handle it. It's a bit more involved than that, of course, but writing clear procedures (including an in-house QA/QC program) to keep the manufacturing staff safe isn't all that difficult.

Where LaserWorld got tripped up is when they stated in the owner's manual that the end user needed to open up the projector to clean the dust out of the fans to prevent the unit from overheating. This contradicted what they wrote elsewhere in the product report: namely that the end user didn't need to open the case for any routine maintenance. Inconsistency is a bad thing and will always get you a hit on a product report.

Furthermore, at one point in the product report they state that the case does not have an intrusion interlock but in leu of that they have used "special screws" to prevent access. When this was found to be incorrect, that was another hit.

Both of these mistakes display LaserWorld's ignorance of the basic CDRH regulations, not to mention a complete lack of understanding of the purpose of a product report. As Dan Goldsmith, Casey Stack, and many others have stated multiple times at the various projector certification presentations we've had at SELEM, "The product report is as much about your manufacturing and certification process as it is about the actual features of the projector."

Put another way, you can do just about anything (within reason) so long as you justify your stance in the product report and demonstrate the methods you plan to use to ensure compliance. Most importantly, you must do what you say you will do, and you MUST be consistent.

Laserworld was using a shotgun approach, trying to cover lots of different things with what they thought was the best answer, but they didn't bother to check for internal consistency before they submitted the report. Sad, really...

Adam

[flecom]

I think you missed the point of that statement. It's not their (the CDRH's) interpretation, but rather yours (as in the person writing the product report) that matters. So long as you are consistent in what you say (within reason), you are OK.

yes but the FDA doc states they were able to remove the screw with a "regular phillips screwdriver" implying that a phillips screwdriver is not a special tool..

Although your product report asserts that “special tools” are required to open the protective enclosure, FDA was able to complete this task by removing typical Phillips screws with a regular Phillips screwdriver.

[JD3]

"(f) Performance requirements --(1) Protective housing. Each laser product shall have a protective housing that prevents human access during operation to laser and collateral radiation that exceed the limits of Class I and table VI, respectively, wherever and whenever such human access is not necessary for the product to perform its intended function. Wherever and whenever human access to laser radiation levels that exceed the limits of Class I is necessary, these levels shall not exceed the limits of the lowest class necessary to perform the intended function(s) of the product.

(2) Safety interlocks. (i) Each laser product, regardless of its class, shall be provided with at least one safety interlock for each portion of the protective housing which is designed to be removed or displaced during operation or maintenance, if removal or displacement of the protective housing could permit, in the absence of such interlock(s), human access to laser or collateral radiation in excess of the accessible emission limit applicable under paragraph (f)(1) of this section.

(ii) Each required safety interlock, unless defeated, shall prevent such human access to laser and collateral radiation upon removal or displacement of such portion of the protective housing

(iii) Either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing shall be provided, if failure of a single interlock would allow;

(a ) Human access to a level of laser radiation in excess of the accessible emission limits of Class IIIa; or

(b ) Laser radiation in excess of the accessible emission limits of Class II to be emitted directly through the opening created by removal or displacement of the interlocked portion of the protective housing."