It would seem if the argument holds that a new product is not being created when incorporating a laser then the supplier of the system is still subject to the CDRH requirements for Dealer and Distributor Records. There's an exception if the retail price is under $50. That's probably 1973 dollars that's never been updated.
-Dave From: Scott Douglas [mailto:[email protected]] Sent: Monday, October 08, 2018 10:25 PM To: [email protected] Subject: Re: [PSES] Does incorporated barcode scanner result in a new laser product? 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]><mailto:[email protected]> Sent: Monday, October 08, 2018 12:08 PM To: TEH EHS Crane, Lauren <[email protected]><mailto:[email protected]>; [email protected]<mailto:[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 - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
