, EMC-PSTC
>Subject: RE: FDA registration of laser
>Date: Wed, 11 Jun 2003 07:50:34 -0400
>
>
>No registration is required if:
>1) You put a Class I laser product into your product (in its entirety) and
>your product is Class I.
>2) You include the documentation that came
Chris -
Your rationale for not resubmitting is valid *if* the GBICs
are Certified as Class I (I haven't seen one yet that
isn't).
Your rationale for resubmitting is missing some what ifs.
Specifically, if you remove (or cover with a label) any of
the required markings or use the device outside t
Nope, you are absolutely correct on the GBIC's or the new smaller pluggable
LC connector optics. You are just a distributor of those under the laser
guidelines. Again, its a fully contained module that you make no changes to,
and they have no controls or failure modes that you could induce to chan
I want to leech off of this question; I hope that I don't get it off track.
We currently produce a module that use GBICs. For the unfamiliar, a GBIC is
an optical transceiver for gigabit ethernet. Our quality personnel handle
CDRH submissions; and our current thinking is that we don't need to r
I think I agree with the laser 42 reference, but I would be a little
careful. The notice applies to units that are not only complete in their
construction and as such their output cannot be affected by the circuits into
which they are being installed. E. g. If the drive voltage increases to
Kim,
You DO need to register. Testing may not be required, but is
strongly encouraged regardless (technically you can refer to the laser
component manufacturer's results).
Note: This is assuming that you aren't just putting an off the shelf
enclosed CD/DVD ROM drive in a system, which shouldn'
Kim -
If the drive is already certified as a Class 1 laser product
and you do not modify it or remove any of the required
markings, you don't need to do anything, irrespective of the
internal laser source's laser class.Refer to Laser
Notice 42 at
http://www.fda.gov/cdrh/radhlth/pdf/laser-not
No registration is required if:
1) You put a Class I laser product into your product (in its entirety) and
your product is Class I.
2) You include the documentation that came with the laser product with your
product.
3) You leave all the labeling on the laser product as you received.
There is an
On Wed, 11 Jun 2003 10:54:36 +0200,
Kim Boll Jensen wrote:
> When using a CD or DVD driver in a product (PC or audio product) and the
> driver is FDA registered, do I need to register the final product at FDA
> too. I can't find a paragraph in 21 CFR which tells me when not to
> register.
I w
As far as I know, yes, you have to register the actual product with the FDA.
That's what I have always done anyway. The fact that the driver is FDA
registered will make it a fairly simple paperwork exercise.
If you think about it, customs will not be able to associate the driver's
FDA accession
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