Lauren,
My question is - is the laser scanner permanently attached/connected
(built-in) to the larger product? If it is, then the combination is
probably a new product. But if all you do is connect a hand held
scanner, for example, and that connection is detachable (USB or RS-232
or some such connector) then I submit the laser scanner is stand-alone
and no further laser product is created. Would not even need to be a
hand-help scanner either. A desk top scanner that is user unpluggable
is still a separate stand-alone product with its own certifications.
Regards,
Scott
On 10/8/2018 1:03 PM, Lauren Crane wrote:
I’ve gotten some direct replies such that I think some additional
perspective might be helpful.
Correct application of the US laser regs requires some significant
attention to fine points. Particularly in light of certified* laser
products available ‘off the shelf’ that are incorporated into another
product to form a new laser product. In addition to the laser
‘standard’ (21CFR1040.10/11) there have been many Laser Notices
published by FDA/CDRH that provide what are effectively exemptions
(scenarios to which they “will not object”). There are particularly
many reliefs for inherently Class I laser products (which may contain
higher classes of embedded lasers) which are themselves then embedded
in another product. Consider the Class III laser in a Class I DVD
drive incorporated into a computer – (which itself is interpreted as
an non-classified laser product, but not completely out of scope since
some of the administrative obligations remain).
So the case I am puzzling over is an appropriately certified* Class II
laser product (the scanner), essentially being bundled with an
industrial machine, but otherwise not modified. As I’ve said, my first
reaction is that a new laser product is being manufactured…. But
perhaps there are some, for example, laser notice fine points I am not
recalling.
*certified in this context means self-declared as compliant to the US
Federal Laser ‘Standard’… it is not related to any sort of electrical
safety certifications.
So if anyone has walked this road before, thanks in advance for
thoughts and guidance, particularly if you think I’ve got it wrong.
Regards,
Lauren Crane
Tokyo Electron
*From:* Nyffenegger, Dave <[email protected]>
*Sent:* Monday, October 08, 2018 12:08 PM
*To:* TEH EHS Crane, Lauren <[email protected]>;
[email protected]
*Subject:* RE: Does incorporated barcode scanner result in a new laser
product?
Yes, I think it’s an appropriate question for this forum.
We’ve followed the CDRH requirements for our products containing class
IV lasers. But now that you raise the question we’ve not followed the
CDRH requirements for our products that contain only Class I and II
lasers and after a quick scan of 21 CFR 1040.10 it appears we should be.
-Dave
*From:*Lauren Crane [mailto:[email protected]]
*Sent:* Monday, October 08, 2018 11:49 AM
*To:* [email protected] <mailto:[email protected]>
*Subject:* [PSES] Does incorporated barcode scanner result in a new
laser product?
I’m not sure this is the correct forum for this question….
Does incorporating a barcode scanner (that happens to be a class II
laser product) into a piece of industrial machinery (e.g., for the
purpose of reading identification tags on work pieces) that otherwise
does not contain a laser result in a new, reportable laser product
under US CDRH requirements?
I’m leaning towards ‘yes’, but I cannot find much guidance on the issue.
Regards,
Lauren Crane
Tokyo Electron
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