I'm going to stick my neck out and say no. Why? Because your product does not interface in an optical manner in any way with the CD. Anything that has to do with laser generation, transmission, reception and use is completely contained within the CD.
I believe one of the understandings with the FDA and the CFR is that your product USES the laser or the collimated light in some way. Yours clearly doesn't. It uses an electronic data bus to interface with the CD. Had a laser interface been used between the CD and your product, then yes, you would have to register with the Radiological dept. of the FDA under 1040 for domestic use and followed IEC825/EN60825 for overseas use. But, please note, this is strictly my interpretation. > From: [email protected] > To: [email protected] > Subject: CD ROM's > Date: Wednesday, July 23, 1997 11:43 AM > > Good Day All: > > I have a question. Perhaps this is not quite the right forum, but I am > hoping that if no one here has the answer that at least you may be able to > point me in the right direction. > > In the U.S. there are FDA requirements for Laser products. > > If I take a CD ROM drive that I have procured from a reputable manufacturer > and which that manufactrurer has properly registered with the FDA (and > which bears the appropriate markings) and I install this INTERNALLY into my > computer product, what are the reporting and labeling requirements for the > end product, my computer ? > > Is my computer now a Laser product, or is the CD ROM drive the Laser > product ? > > I am assuming here that the Laser in the CD ROM is Class I (I hope and > believe that this is typically the case). > > If my end product is not a computer, but rather a piece of Test and > Measuring Equipment does that change anything ? > > What about the rest of the world ? If I comply with IEC825/EN60825, are > there any other countries where there are additional reporting and labeling > (or other) requirements ? > > Your comments will be very much appreciated. > > > Richard Payne > Tektronix, Inc. > [email protected]
