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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