Laser Safety
All,
This morning I had a long
conversation with CDRH (CDRH will be the personification of the individual I
talked to. I am trying to avoid his receiving a plethora of calls which he
doesn't have time to handle).
CDRH has recently received
Geoff's (802.3's) liaison letter and is working on a
response.
There is some risk in my
documenting this conversation since there may potentially be differences
between what you read here and what the official response will be. I take that
risk in hopes that this note will provide benefit to the committee at large in
preparing for the July meeting.
Firstly, CDRH is
unwilling to make any guess of the likelihood of the IEC approving the Final
Draft International Standard (FDIS). The FDIS is due out the end of June. It
will go into a 2 month voting cycle. During this cycle, only YES or NO votes are
allowed. No abstains. No comments. If passed, the international standard could
be in place by Oct, 2000. If any indication of support can be had from the past
voting, last summer the committee voted 15:1 to forward the work to a CDV
(committee draft for vote) to prepare the document.
CDRH presented a plan to
the FDA last Sept regarding a strong desire to harmonize with the IEC changes.
This direction was strongly supported with recommendation to proceed with "all
due haste." The US version is being drafted now. It is likely to differ from the
IEC version in structure, format, and layout. It will also differ in support of
LEDs. There are no technical differences EXPECTED for laser
launches.
Following a positive IEC
vote, CDRH (et. al.) will refine the US proposal and put it in the FDA queue.
Once in queue it will compete in priority with all the other work going through
the agency. CDRH was unwilling to speculate on the length of time to
approval.
During this time, CDRH (the
organization) will entertain variances on an individual basis. There is no
guarantee that these would be granted, but the indication is that these would be
looked on favorably (meaning more positive than negative) under the assumptions:
IEC approval; a completed US version that "harmonizes" with the IEC version;
entry into the FDA queue; an otherwise well documented and reasonable
request.
jonathan
p.s. You will note that I
have quoted little in this note. That was intentional. You should read into this
note every possible disclaimer that can be imagined. In short, use this
information at your own risk. Assume there are errors. If you plan a business
strategy based on this note you are outright stupid. How's that for the "fine
print (rhetorical question, please don't answer)?"
Jonathan Thatcher,
Chair, IEEE 802.3ae (10 Gigabit
Ethernet)
Principal Engineer, World Wide Packets
PO BOX 141719, Suite B;
12720 E. Nora, Spokane, WA 99214
509-242-9000 X228; Fax 509-242-9001;
jonathan@xxxxxxxxxxxxxxxxxxxx