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Old 07-17-2014, 06:11 PM #1
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Exclamation Aug 3 2014 deadline for comments on FDA laser pointer proposal

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 You may recall that FDA was presenting "draft guidance" saying they were going to regulate pointers and handheld lasers as "surveying, leveling or alignment" (SLA) lasers.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

=========================

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FDA's Draft Guidance would control these uses by first stating that SLA lasers have certain design features.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.
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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Old 07-17-2014, 09:35 PM #2
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Default Re: Aug 3 2014 deadline for comments on FDA laser pointer proposal

I agree we all need to be very vigilant in opposing this legislation. Off/On topic, how will/could/would this law affect the typical hobbyist?
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Old 07-17-2014, 11:10 PM #3
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Default Re: Aug 3 2014 deadline for comments on FDA laser pointer proposal

If the FDA adopts their proposed guidance, the biggest change would be that handheld lasers above 5 mW would become illegal to sell in the U.S.

I believe FDA would not have the power nor the desire to come after lasers you already own. Their proposal would only affect future sales of handhelds.

How a hobbyist like yourself is affected, depends on how you get your lasers:
  • If you buy pre-made handheld lasers (those above 5 mW) over the Internet, the supply may dry up -- they would be illegal to import or sell. Or it may be harder to find them; you'd have to go "underground".
  • If you make your own lasers out of modules and power supplies, then you're probably OK. Right now I do not see FDA cracking down on components, or on individuals making their own lasers for personal use.

The main pointer/handheld problems the FDA sees are from ordinary citizens who have gotten ahold of a laser, and who use it improperly. So one key goal of the Draft Guidance is to give FDA the ability to remove ordinary citizens' access to handheld lasers over 5 mW. (People could still get pointers that are less than 5 mW, just like today.)
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Old 07-17-2014, 11:19 PM #4
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Default Re: Aug 3 2014 deadline for comments on FDA laser pointer proposal

Typical FDA, reaching there stupid little hands into business that is in no way related to them.

Quote:
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."
This made me chuckle. Hopefully some of those idiots will read that and realize they aren't fooling anyone by classifying laser pointers as SLA's.

And lets be honest, even if this does get passed, it will be some time until truly no >5mW lasers will be able to be had. I could see sellers, say, laserBTB just putting a "5mW" sticker on an HL300-532 and selling it to us anyway (unless they start equipping every post office with power meters). That's just one example. There will be always ways to get what we want.
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Old 07-17-2014, 11:36 PM #5
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Default Re: Aug 3 2014 deadline for comments on FDA laser pointer proposal

this proposal is dumb.. i got bit by a dog over 5 lbs once therefore we should ban all dogs over 5 lbs.... yeaaaa "logic"
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Old 07-28-2014, 10:30 AM #6
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Default Re: Aug 3 2014 deadline for comments on FDA laser pointer proposal

Quote:
Originally Posted by pmurph5 View Post
  • If you buy pre-made handheld lasers (those above 5 mW) over the Internet, the supply may dry up -- they would be illegal to import or sell.
Battery operated pointers over 5mw have been illegal to import, sell retail and private resale for a long time.

Quote:
Originally Posted by pmurph5 View Post
  • If you make your own lasers out of modules and power supplies, then you're probably OK. Right now I do not see FDA cracking down on components, or on individuals making their own lasers for personal use.
The FDA does not regulate the hobby of laser construction.

Last edited by steve001; 07-28-2014 at 10:30 AM.
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Old 07-28-2014, 10:38 AM #7
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Default Re: Aug 3 2014 deadline for comments on FDA laser pointer proposal

Quote:
Originally Posted by crazyspaz View Post
Typical FDA, reaching there stupid little hands into business that is in no way related to them.



This made me chuckle. Hopefully some of those idiots will read that and realize they aren't fooling anyone by classifying laser pointers as SLA's.

And lets be honest, even if this does get passed, it will be some time until truly no >5mW lasers will be able to be had. I could see sellers, say, laserBTB just putting a "5mW" sticker on an HL300-532 and selling it to us anyway (unless they start equipping every post office with power meters). That's just one example. There will be always ways to get what we want.
Suggesting or planned circumventing the law isn't the way to shed a positive light on us. People breaking the law is the precise reason the FDA wants greater authority over laser designations. Think about it.

Last edited by steve001; 07-28-2014 at 02:20 PM.
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