Thanks Martin, Notice 42 makes it clear. I can only think the guy I talked
to at CDRH either didn't know about it or he is interpreting it to only
include the examples noted in the notice (CD players, etc. where the laser
is totally buried in the product). My application is similar to yours where
I provide an optical communications interface which uses a Class 1 laser
module.
Regards,
Scott Lemon
email: sle...@caspiannetworks.com
-Original Message-
From: Martin Lindquist [mailto:mlind...@cisco.com]
Sent: Thursday, March 22, 2001 10:07 AM
To: emc-p...@majordomo.ieee.org
Subject: RE: FDA laser classes
Scott,
My understanding is that (for our Class I components (OC3 transceivers) at
least), according to Notice 42 (Dec. 18, 1989), initial and annual reports
are not required if you comply with the four points listed (see actual
notice for more information):
1. No modification of performance or intended use and incorporation of
the certified product results in only the concealment of the original
manufacturer's certification and identification labels required by 1010
2. The labeling requirements of 1010 and 1040.10 would be met if the
certified product were removed from the product in which it was incorporated
3. The labeling requirements of 1040.10(g) would be met in any service
configuration of the certified product
4. The laser safety information provided by the certifying manufacturer
is distributed with the product
Jumping into Table 1 of Part 1002 there is no requirements for
Distribution records. I even went so far as to verify this (via email) with
the CDRH last year. Note that this is for a Class I OC-3 laser module
component used by us in its intended use and manufactured by someone else
(HP, etc), where the manufacturer has done all the filing, attestations,
etc., and where the module does not contain a higher Class laser. In other
words, according to the CDRH and Notice 42 we are a 'distributor' of the
module and thus not subject to initial and annual reports, nor is any
additional certification and identification labels required on the outside
of the final product.
Your situation may well require the 5 points you list, but take a look at
Notice 42 (and Notice 41 as well (Aug. 9, 1988)), along with the other
notices in the following PDF (link provided to me by John Juhasz). Your
compliance contact may not have been aware of these, or he may be holding
you to a higher standard than is required by the CDRH, I can't say.
Notices:
http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf
http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf
(Notice 42 is page 87 of 105)
Reporting form:
http://www.fda.gov/cdrh/radhlth/pdf/lasrpt0p.pdf
http://www.fda.gov/cdrh/radhlth/pdf/lasrpt0p.pdf
If nothing else, you may have learned something new today and be able to
go home early... :)
Martin.
-Original Message-
From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On Behalf Of
Scott Lemon
Sent: Thursday, March 22, 2001 8:00 AM
To: 'Bandele Adepoju'; 'John Juhasz'; 'Martin Lindquist'; '|Moshe Valdman'
Cc: emc-p...@majordomo.ieee.org
Subject: RE: FDA laser classes
Bandele,
This is not my understanding after talking to a compliance specialist in
CDRH yesterday. He informed me that manufacturers that incorporate class 1
lasers (which have themselves followed the required reporting requirements,
etc. per the CFR and CDRH guidelines) must still:
1. file an initial product report per 1002.10
2. file an annual report per 1002.13
3. file a report of accidental radiation occurrences (as applicable) per
1002.20
4. end product must have a certification label per 1010.2
5. end product must have an ID label per 1010.3
He indicated that all other reporting requirements (including supplemental
reports) are not required of the end product manufacturer.
This seems to correlate somewhat with the Aug 23, 1985 notice (at least the
second to the last paragraph).
I contacted Mr. Manuel Karos at CDRH (non-medical lasers) at (301) 594-4646.
This was my understanding - it might not be a bad idea if someone else wants
to contact the office as well to substantiate and report back to the group.
Regards,
Scott Lemon
sle...@caspiannetworks.com
-Original Message-
From: Bandele Adepoju [mailto:badep...@jetstream.com]
Sent: Wednesday, March 21, 2001 8:09 PM
To: 'John Juhasz'; 'Martin Lindquist'; '|Moshe Valdman'
Cc: emc-p...@majordomo.ieee.org
Subject: RE: FDA laser classes
Hello all,
Manufacturers who only incorporate certified Class 1 lasers into their
products
only need to comply with the record keeping requirements of 21CFR 1002.
They do not need to submit initial and annual reports.
Regards,
Bandele
Jetstream Communications, Inc.
badep...@jetstream.com mailto:badep...@jetstream.com
-Original Message-
From: John Juhasz [mailto:jjuh...@fiberoptions.com]
Sent: Wednesday, March 21, 2001 8:19 AM
