Doug, et al - The FDA is concerned about contacting a responsible company, should any incident(s) occur for any given product. This would be to affect recalls and/or repairs/modifications, etc., to Certified equipment. Also, this is intended to allow a user to contact the responsible company with any questions regarding safe use of the product.
If Company A's logo is on the product, Company A generally becomes the certifier of the laser product and reports to the FDA. However, the rules and reports allow for brandlining of products, so that the responsible company can be other than the company with the logo on the product, provided the FDA _and_the_user_ has traceability to the responsible company. This implies to me that Company B must have their name and address on the product, even if brandlined to Company A. This latter point might be open for discussion. If I were Company A, I'd be leery of this, unless I initiated the idea. If company A initiated the idea, they should report to the FDA and identify Company B as an assembler or manufacturer. BTW, the CDRH Rules often refer to "manufacturer." This is intended to mean "responsible company" or "certifier." I suppose the rules were written at a time when less brandlining occurred. This all sounds like too complicated an affair that would get the lawyers howling and make for messy contracts. I hope I'm never asked to do this. Regards, Peter L. Tarver Homologation Engineering Dept. 4P02-4 MPK MS: D-2120 V: ESN 655-2453 F: ESN 655-2575 >---------- >From: Doug McKean[SMTP:[email protected]] >Sent: Thursday, December 04, 1997 11:58 AM > >Maybe I'm making this too complicated. > >Say Company A makes a laser product that >incorporates a Class IIIb laser system. > >Company B comes along, buys the laser product >from Company A, puts a Company A logo on it, >and sells it as a Company A product with a >Company A model number. > >Who registers with the FDA? > >Company B, I assume, since the registration >with the FDA is with model numbers. > >What are the issues with liability? >Company B I assume? > >********************************************* > Some of the time, where there's a will, > there's a way. > Most of the time, where there's a will, > there's relatives ... >--------------------------------------------- > "It is vain to do with more > what can be done with less." > William of Occam (c. 1285 - 1349) >********************************************* > >
