Mike, Go to the following link of the CDRH (Center for Devices and Radiological Health). They're the ones to whom the reports will be sent. There are further links to information that will be very useful to you and should answer most of the questions you posed below.
http://www.fda.gov/cdrh/radhlth/index.html Simply put, at this moment in the US LEDs are not regulated. But the CDRH will be aligning the regs with Europe (EN 60825) where verification that the LEDs are safe is required. GE Interlogix John A. Juhasz Fiber Options Div. Bohemia, NY > -----Original Message----- > From: Davis, Mike [mailto:mda...@c-cor.net] > Sent: Wednesday, June 19, 2002 9:59 AM > To: Emc-Pstc (E-mail) > Subject: Two Questions concerning the subject of Laser Safety > > 1. Are manufacturers required by the FDA to record serial numbers of > Laser modules. Where is this requirement located? Does this apply to > photodiodes also? > > 2. I have a concern of what I need to know about Laser safety but was > afraid to ask (because it would cost more than my compliance budget ($0) > would allow without manager approval). In other words (what is the second > question?... I am getting there.) I am looking to hire a consultant or > take a course. My supervisor wants me to create for him a proposal > answering the type of questions that support the need to either attend a > course or have a consultant educate me or our professionals here so that > he can decide whether or not we need to hire a consultant, etc, etc. To > keep this short, I will paraphrase by saying that the type of questions he > would like to have answered is it worth the expense to getting smart, as > engineers and a manufacturer of ITE, in the manufacturing of laser > systems? > > Here is my question... > Is there information available that summarizes the responsibilities to > Laser Safety of Compliance, Design, Manufacturing, and Test Engineers that > manufacture laser systems? > > You may respond either on or off line. Thanks in Advance! > > > Michael S. Davis > Compliance Engineer > C-C0R.net > Tel: 203.630.5788 > Fax: 203.630.5762 > mike.da...@c-cor.net > > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
