I thought you did pre-market notification with CDRH for laser products. I was not aware you register them. Besides, CDRH does not review the reports you send them. They acknowledge that they got them and that's that. You will find out more when the FDA audits your facility about what procedures need to be followed unless you are aware of the audit procedures FDA uses. There is an audit document FDA uses and it is on the FDA web site.
Also, use the FDA eSubmitter software to file reports, it's worth it if you have a lot of laser products and want to get quick turn around on submittals. Best regards, Ron From: [email protected] [mailto:[email protected]] On Behalf Of Andrew Robbins Sent: Friday, January 27, 2012 9:45 AM To: John Cotman; [email protected] Subject: RE: [PSES] I'm at a loss on lasers Lasers sold in the US must be registered with the FDA. Sold in the EU you can self declare. Laser standards apply to an end product, not the laser subassembly(I find many manf's don't realize this fact). The requirement to test a laser is driven by the safety standard that applies to the end product, such as 60950 or 61010. Hence laser safety is declared under the LVD. There are differences in the way lasers are treated in the US and EU, but the purpose is the same, eye safety. LEDs have recently come into popular use for general illumination and their high output has pushed them into the laser category. That will eventually change, but for now the standards overlap. In response to Gary comments, the FDA is responsible for laser on the US market, but no general product electrical safety, which falls under OSHA and NRTLs(UL etc). Yes, they spend much more time and effort on medical use laser for obvious reasons, but don't think they won't crack down on misuse in other sectors as well. You are required to submit and file a Product Report to the US FDA CDRH in the required FDA format. You are required to file an Annual Report to the US FDA CDRH in the required FDA format. You are required to maintain a FDA Radiation Testing Report for when the FDA chooses to inspect your facility. You are required to maintain a FDA Dealer and Distribution Report for when the FDA chooses to inspect your facility. When applicable, you are required to submit and file a Supplemental Report, Defect Report, Incident Report and/or Variance Report to the US FDA CDRH. You are not exempt from any of this required FDA Reporting and recordkeeping. None of this is as tough as it sounds. The FDA does not do much "policing" of the market except when laser are used in medical devices, but use caution and follow the rules just the same. US FDA CDRH 21CFR applies in the US EN 60825-1 applies in EU They are similar, NOT the same. Do not stumble across LN50 and jump to the conclusion that one standard covers both markets as this is a common misconception. That doc describes harmonization of test procedures, not test report of methods of claiming/proving conformity. Contact me offline with product info and I will be happy to guide you on what needs to be done in the US/CAN/EU. Andrew Robbins 813-528-1261 cell From: John Cotman [mailto:[email protected]] Sent: Friday, January 27, 2012 4:32 AM To: [email protected] Subject: Re: [PSES] I'm at a loss on lasers "I don't see any hint of a EU directive just the CE mark but without reference to directives. It could simply mean that they have RoHS. " The current RoHS is not a CE marking directive. The newly published one will be, but it hasn't taken legal effect yet. This does not, of course, answer your laser question. John C _____ From: McInturff, Gary [mailto:[email protected]] Sent: 26 January 2012 23:56 To: [email protected] Subject: [PSES] I'm at a loss on lasers Does anybody have a succinct answer to the relationship between the FDA and safety approvals? The FDA just seems to classify the maximum out of a laser component, and quite often is class III - and identifies it as harmful to the eye. If I use the device in a product then we have to be concerned with safety approvals of the requisite standard and they require class I output if the beam comes out of the enclosure. The FDA doesn't care about product standards other than medical standards. UL will recognize a laser, imposing fault requirements that the FDA doesn't seem to impose, and will do an EN60825 evaluation as well. They do this with the help of the CDRH report filed with the FDA. Again they will classify the laser in alignment with the CDRH report, but the still apply the end product beam requirements. The FDA seems to care about classification and tracking of the device but not implementation. If class III is hazardous how does one make a gun sight laser for the commercial market without violating in the US or EU directives. I see a package marking that has the CE mark, but who can tell what that means without the DoC - could just be RoHS as far as I can tell. Trying to get the program manager off my back - he's hell bent for leather - charging head because he found the gun sight on the market and that's enough for him. I don't actually blame him, but I need to understand the details a bit more than that. I think I might be wrapped around the axel a little too tightly - the world is full of inherently dangerous things - guns and knives. Should I just be recommending that we grab any only FDA classified laser, put it in the product and sell it hither and yon, like a gun or a knife without product standards. How about the EU - just how does that work - I don't see any hint of a EU directive just the CE mark but without reference to directives. It could simply mean that they have RoHS. Scans of the CDRH report requirements itself are helpful but don't address the relationship between FDA classification and safety control Crud Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, MEMTRON, and LRE MEDICAL products 600 W. Wilbur Avenue Coeur d'Alene, ID 83815-9496 Office:208-635-8306 Cell: 509 868 2279 Toll Free: 800-444-5923 X 1238 [email protected] <mailto:[email protected]> <http://www.esterline.com/advancedinput> www.esterline.com/interfacetechnologies Technology, Innovation, Performance... - ---------------------------------------------------------------- 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://listserv.ieee.org/request/user-guide.html 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]> - ---------------------------------------------------------------- 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://listserv.ieee.org/request/user-guide.html 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]> - ---------------------------------------------------------------- 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://listserv.ieee.org/request/user-guide.html 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]> - ---------------------------------------------------------------- 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://listserv.ieee.org/request/user-guide.html 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]>
