This is a reminder that August 3 2014 is the deadline for the public to submit comments on FDA's May 5 proposal to essentially limit handheld lasers to below 5 milliwatts.
This was first discussed in a thread back on May 2. You may recall that FDA was presenting "draft guidance" saying they were going to regulate pointers and handheld lasers as "surveying, leveling or alignment" (SLA) lasers.
If enacted, this would mean that any handheld laser could not exceed the SLA limit of 5 mW.
After reading the proposal, I thought there were many problems with it. I was ill during June, but now have finally caught up. I have written a 20-page comment which is available here. If you are interested, click the link and check out the details.
If you want to read the FDA's full proposal, which includes instructions for submitting comments, it is here.
Below is a summary of the FDA's proposal, and of my objections to their proposal.
Thank you for your interest,
-- Patrick Murphy
Writing on behalf of myself, and not any group, organization or association
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SUMMARY OF FDA'S PROPOSAL, AND MY COMMENTS OPPOSING IT
21 CFR 1040.10 and 1040.11 gives FDA authority over three uses of lasers: 1) surveying, leveling or alignment (SLA), 2) demonstration which includes laser light shows and 3) medical. The regulation does not mention or give FDA direct authority over laser pointers, gun sights, night vision illuminators, laser dazzlers or other uses that FDA now proposes to control.
FDA's Draft Guidance would control these uses by first stating that SLA lasers have certain design features. FDA says these are: compact size, battery power, hand-held ergonomics, portability, an aperture where a beam comes out, and a straight-line beam.
FDA then says that because SLA lasers have these features, lasers that have these features (pointers, gun sights, etc.) are SLA lasers. They will be limited to the 5 mW output limit of SLA lasers.
My comments make five basic points about pointers and handhelds, as they relate to SLAs:
Based on this, I then urge the FDA to rescind the Draft Guidance, and not to regulate pointers and handhelds based on them being (incorrectly) called "surveying, leveling or alignment" lasers. If FDA wants to regulate pointers and handhelds, they should do this the right way, by seeking a Congressional law giving them the authority they seek.
These ideas are explored in more depth in my 20-page comment submission, which is available here.
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This was first discussed in a thread back on May 2. You may recall that FDA was presenting "draft guidance" saying they were going to regulate pointers and handheld lasers as "surveying, leveling or alignment" (SLA) lasers.
If enacted, this would mean that any handheld laser could not exceed the SLA limit of 5 mW.
After reading the proposal, I thought there were many problems with it. I was ill during June, but now have finally caught up. I have written a 20-page comment which is available here. If you are interested, click the link and check out the details.
If you want to read the FDA's full proposal, which includes instructions for submitting comments, it is here.
Below is a summary of the FDA's proposal, and of my objections to their proposal.
Thank you for your interest,
-- Patrick Murphy
Writing on behalf of myself, and not any group, organization or association
=========================
SUMMARY OF FDA'S PROPOSAL, AND MY COMMENTS OPPOSING IT
21 CFR 1040.10 and 1040.11 gives FDA authority over three uses of lasers: 1) surveying, leveling or alignment (SLA), 2) demonstration which includes laser light shows and 3) medical. The regulation does not mention or give FDA direct authority over laser pointers, gun sights, night vision illuminators, laser dazzlers or other uses that FDA now proposes to control.
FDA's Draft Guidance would control these uses by first stating that SLA lasers have certain design features. FDA says these are: compact size, battery power, hand-held ergonomics, portability, an aperture where a beam comes out, and a straight-line beam.
FDA then says that because SLA lasers have these features, lasers that have these features (pointers, gun sights, etc.) are SLA lasers. They will be limited to the 5 mW output limit of SLA lasers.
My comments make five basic points about pointers and handhelds, as they relate to SLAs:
1) SLA lasers require stable tripods or mounts in order to do surveying, leveling or alignment. But almost by definition, a laser held in the hand cannot do any (accurate) surveying, leveling or alignment.
2) SLA lasers look very different from pointers and handhelds. A simple Google Image search for "surveying lasers" or "leveling lasers" shows how different they are from the simple penlight/flashlight look of pointers and handhelds.
3) Regarding FDA's claimed design features that are specific to SLAs, FDA is either incorrect or has chosen features which are not specific only to SLAs. For example, many other laser products are compact, or are battery powered, or have an aperture, or emit a straight line.
4) It is a logical fallacy to say "Because SLAs have some features, lasers with those features are therefore SLAs". This is like saying "All surveyors are people; therefore, all people are surveyors."
5) SLAs are already clearly defined in 21 CFR 1040.10(b)(39). They do not need further redefinition based on incorrect or non-specfic features cherry-picked by FDA.
2) SLA lasers look very different from pointers and handhelds. A simple Google Image search for "surveying lasers" or "leveling lasers" shows how different they are from the simple penlight/flashlight look of pointers and handhelds.
3) Regarding FDA's claimed design features that are specific to SLAs, FDA is either incorrect or has chosen features which are not specific only to SLAs. For example, many other laser products are compact, or are battery powered, or have an aperture, or emit a straight line.
4) It is a logical fallacy to say "Because SLAs have some features, lasers with those features are therefore SLAs". This is like saying "All surveyors are people; therefore, all people are surveyors."
5) SLAs are already clearly defined in 21 CFR 1040.10(b)(39). They do not need further redefinition based on incorrect or non-specfic features cherry-picked by FDA.
Based on this, I then urge the FDA to rescind the Draft Guidance, and not to regulate pointers and handhelds based on them being (incorrectly) called "surveying, leveling or alignment" lasers. If FDA wants to regulate pointers and handhelds, they should do this the right way, by seeking a Congressional law giving them the authority they seek.
These ideas are explored in more depth in my 20-page comment submission, which is available here.
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