[email protected] wrote: > > Hello all, > > Way back when, there was some discussion on laser products classifications. > > Right now, we are new to the use of lasers and their regulations. I have > some basic knowledge of the regulations, due to long ago testing of them, > and my gray matter is not what it used to be. > > I would appreciate some assistance in the following: > > 1) Where do I get the latest copy of the CDRH report? > Name, contact, address, tel., etc.
It's been almost a year, but you can start here: JEROME E. DENNIS ACTING CHIEF FOOD AND DRUG ADMINISTRATION NON-MEDICAL RADIOLOGICAL DEVICES BRANCH OFFICE OF COMPLIANCE (HFZ-342) CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 2098 GAITHER ROAD ROCKVILLE, MD 20850 Main Tel # 1-301-770-5553 > 2) Filing procedures. I suspect it will be in the CDRH report that must be > filled out. As I remember it, it was every year and I had to note the > vendors model name, quantity and what product we were using the laser for. Yes. The reports I filled out followed the format of the standard. The FDA hands out a summarized handbook. I just went through it paragraph by paragraph answering with the necessary information. > 3) Labeling format will be in 21 CFR section 1040???? Well, it all depends upon you class of laser system, i.e. Class I, II, IIIb, IV, ... Remeber, a "laser system" is the laser component inside your product. A "laser product" is your device that uses the laser system. Make sure you understand this distinction before filling out the reports. > 4) Any European document detailing who tests the laser for proper > usage/application in a larger product, labeling requirements (multiple > language????) IEC-825. Last I knew, TUV in Newtown CT had someone able to do product review to 825 for Europe. Check with them and any other labs. > Any addition information would be most appreciated, as it is sometimes > difficult to ask the right questions. Send your registration info to the FDA by REGISTERED mail. The FDA last I knew would "acknowledge" your registration date as the date on the mail. It will take months to wait for an answer back from them. They DO NOT approve your product. They only acknowledge recieving your information package. Your information package should include: 1. your completed laser report, 2. user manual, 3. product manual, 4. component info from the laser mfr., 5. point of contact for your company, 6. all effected assembly numbers/product model numbers, 7. any other info you see fit to include. > Richard Georgerian > Product Compliance Eng. > Exabyte > tel.: 303-417-7537 fax: 303-417-7829 e-mail: [email protected] > ******************************************************* ------------------------------------------------------- The comments and opinions stated herein are mine alone, and do not reflect those of my employer. ------------------------------------------------------- *******************************************************
