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:[email protected]] Sent: Monday, October 08, 2018 2:02 PM To: [email protected] 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 <[email protected]> Sent: Monday, October 8, 2018 9:51 AM To: [email protected] 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 <[email protected]<mailto:[email protected]>> Sent: Monday, October 08, 2018 11:15 AM To: TEH EHS Crane, Lauren <[email protected]<mailto:[email protected]>>; [email protected]<mailto:[email protected]> 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%7C1c92841537674ec4ab7408d62d4079a0%7C72f988bf86f141af91ab2d7cd011db47%7C1%7C0%7C636746152287382780&sdata=vUiXYrOrayVHzr2fgCHMse6QXWTT2snLVNxphnJxnNI%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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