I never said that the initial report would be easy. I only indicated that it would be simplified with proper test data from the manufacturer of the laser. If the laser manufacturer can provide a detailed report, the initial CDRH submittal shouldn't be too bad. I also didn't state that the annual report would be hard. I only indicated it would be a hassle. It is an unnecessary process in my opinion. The CDRH doesn't approve submittals and only sends out an acknowledgement that they received it. I have no evidence, but I suspect they spend even less time handling the annual reports. To me, sending in an annual report that will likely get filed away without any useful purpose makes the filing a hassle. It's quick and easy and doesn't take much time, but if it's useless to everybody, get rid of the requirement and save everybody the work. However, the FDA still hasn't finalized Laser Notice 56 and they are years behind on IEC 60825-1 3rd Edition. I wouldn't expect them to make progress on updating something more basic to the process of how they work.
Ted Eckert Microsoft Corporation The opinions and ranting expressed are my own and do not necessarily reflect those of my employer. From: Nyffenegger, Dave <dave.nyffeneg...@bhemail.com> Sent: Monday, October 8, 2018 5:04 PM To: Ted Eckert <ted.eck...@microsoft.com>; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: [PSES] Does incorporated barcode scanner result in a new laser product? The annual report is pretty basic, just requires some basic production record keeping along with any documented product issues. The initial product report and any follow-up supplementary reports are a lot of work. -Dave From: Ted Eckert [mailto:000007cf6ebeab9d-dmarc-requ...@ieee.org] Sent: Monday, October 08, 2018 2:02 PM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] Does incorporated barcode scanner result in a new laser product? Hello Lauren, As far as I am aware, the FDA only has reduced reporting and recordkeeping requirements if you incorporate a Class I laser into your product. Laser Notice 54 gives some additional information, but the intention is that a computer manufacturer doesn't have to do extra work if they include a DVD drive made by another company. Your initial CDRH submittal may be simplified if the provider of your Class II laser can provide a test report or an existing Accession Number. The annual reporting requirements will likely still be a hassle. Ted Eckert Microsoft Corporation The opinions expressed are my own and do not necessarily reflect those of my employer. From: Lauren Crane <lauren.cr...@us.tel.com<mailto:lauren.cr...@us.tel.com>> Sent: Monday, October 8, 2018 9:51 AM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] Does incorporated barcode scanner result in a new laser product? John, I tend to agree with you, but I've been fighting regulatory dragon's long enough to know there can sometimes be fine point details or 'special scenarios' I am not aware of. It never hurts only hurts a little to ask. -L From: John Woodgate <j...@woodjohn.uk<mailto:j...@woodjohn.uk>> Sent: Monday, October 08, 2018 11:15 AM To: TEH EHS Crane, Lauren <lauren.cr...@us.tel.com<mailto:lauren.cr...@us.tel.com>>; EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] Does incorporated barcode scanner result in a new laser product? Little guidance, perhaps, because there is little reason to suppose 'no' is a possible answer. John Woodgate OOO-Own Opinions Only J M Woodgate and Associates www.woodjohn.uk<https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.woodjohn.uk&data=02%7C01%7CTed.Eckert%40MICROSOFT.COM%7Cbea349c579b94474d12408d62d7abc5e%7C72f988bf86f141af91ab2d7cd011db47%7C1%7C0%7C636746402523036604&sdata=hJ2%2FAs7%2BfDwZbEfsmDPcXYwCvjf75VP0i4AOkoiwpPw%3D&reserved=0> Rayleigh, Essex UK On 2018-10-08 16:48, Lauren Crane wrote: 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. 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