Richard, It is my understanding that the FDA requires any product incorporating a laser to be registered with the CDRH. I have a similar situation with a remote we manufacture that incoporates a laser as a pointing device. Even though our supplier has the laser registered, we must still register the end product that utilizes the laser. It is largely a paperwork job, but we must test the device for proper output level and insure the labling and warnings are correct. CD ROM's in a computer may be different. There is a good article on laser requirements in Compliance Engineering May-June 1996
Darrell Locke Advanced Input Devices ---------- From: [email protected] To: [email protected] Subject: CD ROM's List-Post: [email protected] Date: Wednesday, July 23, 1997 8:43AM 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]
