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-   -   Help a newbie : US FDA Importation Requirements (http://laserpointerforums.com/f53/help-newbie-us-fda-importation-requirements-90742.html)

EpicHam 08-23-2014 07:53 AM

Help a newbie : US FDA Importation Requirements
 
Hello everyone.
I'm pretty new to selling lasers on the internet internationally so I need someone to mark if I've fulfilled all the FDA requirements for laser importation into the states.


I'm looking at the FDA Laser Import Guidance as we speak.

It has quite a few requirements so I'll list them out .
  1. 1: Standard Specifics Performance Requirement :
    Since this is a class IV laser , its's gonna require all 4 of the FDA laser safety interlock systems and yes it is labelled off factory . So
    Check

  2. 2: Applicability : I'll state it as a portable laser system for research purposes.
    Well.. considering the nature of CNI , it pretty much is. CNI only does handheld lasers as a side business anyway , you can only buy a CNI in a group buy mostly.
    Check

  3. 3: Protective Housing : A sturdy housing that prevents unauthorized or accidental access to the laser source. Check , its built like a tank .

  4. 4: Safety Interlock System :
    • Emission indicator , there's a red light that lights up when the laser is activated.
    • Snap action switch that shorts the laser when its removed. (The jack bridge at the rear cap)
    • Key control. (you get a spare key too)
    • Beam attenuator , fancy word for beam shutter , will be shipped to you.
    • Operating controls are behind the laser source , so check.
  5. 5: Informational requirement:
    • User information containing instructions for safe operation , check.
    • Radiation specifics , check.
    • Reproduction and location of labels , check.
    • Listing of all the controls and adjustments ,check.
    • Caution statement , check.



So basically unless you have been pissing in the custom officer's coffee he has NO legal reason whatsoever to detain it.

Right?
Right?



Here's the link to the FDA requirement document btw.
http://www.fda.gov/downloads/Medical.../UCM095304.pdf




I'm trying to sell this laser btw.
http://laserpointerforums.com/f39/fs-532nm-500mw-green-laser-cni-pgl-iii-c-90623.html

Encap 08-23-2014 09:46 AM

Re: Help a newbie : US FDA Importation Requirements
 
See: Laser Pointer Safety - Rules and regulations in the U.S. (For those selling laser pointers)

EpicHam 08-23-2014 03:55 PM

Re: Help a newbie : US FDA Importation Requirements
 
so.... did I pass?

Encap 08-23-2014 05:46 PM

Re: Help a newbie : US FDA Importation Requirements
 
Contact FDA to see if you passed. I would guess, no you did no pass.

CNI no longer ships handhelds to USA because if inspected they are subject to detention.

Regulations and practices have changed.

Basically anything over 5mW you can forget about shipping to to USA legally.

See: "UPDATE May 2 2014: The FDA today announced its intent to effectively ban the sale of laser pointers and handhelds over 5 milliwatts." Laser Pointer Safety - FDA authority over laser pointers and handheld lasers

EpicHam 08-23-2014 05:47 PM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by Encap (Post 1319274)
Contact FDA to see if you passed. I would guess, no you did no pass.

CNI no longer ships handhelds to USA because if inspected they are subject to detention.

Regulations and practices have changed.

Basically anything over 5mW you can forget about shipping to to USA legally.

See: "UPDATE May 2 2014: The FDA today announced its intent to effectively ban the sale of laser pointers and handhelds over 5 milliwatts." Laser Pointer Safety - FDA authority over laser pointers and handheld lasers

so.. any tips and tricks?

mortuus 08-23-2014 11:01 PM

Re: Help a newbie : US FDA Importation Requirements
 
fda are crazy, you would have to buy something cheap and hope you get it lol.

Hap 08-24-2014 12:27 AM

Re: Help a newbie : US FDA Importation Requirements
 
One thing I can recommend to "improve" your chances of having your laser pass US Customs is the well-known trick of shipping it without batteries. Most 5mW+ lasers which aren't shipped with the bats included pass(but it isn't a guarantee).

Best of luck on the sale :)

-Alex

ultimatekaiser 08-24-2014 12:42 AM

Re: Help a newbie : US FDA Importation Requirements
 
You can own a laser of any power in the USA as long as it meets the performance standards for CDRH and FDA safety, has an ascession number, and runs on mains power. (i.e. It runs on the wall power only)

However, anything portable or running on batteries over 4.9mW is not permitted...Period.

Edit: for the noob who neg rep'd me read below -.- that was uncalled for

steve001 08-24-2014 03:04 AM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by ultimatekaiser (Post 1319348)

However, anything portable or running on batteries over 4.9mW is not permitted...Period.

Stop with the wrong interpretation of the law.

ultimatekaiser 08-24-2014 03:45 AM

Re: Help a newbie : US FDA Importation Requirements
 
It's not wrong. I've asked. You can legally own them, and use them privately. But handhelds over class IIIa are not allowed for import or sale in the USA. I've been told this, both by customs and by the variance/ascession office.

Edit:
I do know that he's selling not buying, and it's only one, the rules are met as long as it is shipped with proper declaration, I see no issue. But that is how it is stated to me import wise. Export is fine, as it meets the standards necessary for the other country/buyer.

EpicHam 08-24-2014 11:12 AM

Re: Help a newbie : US FDA Importation Requirements
 
So uh..... if it does get inspected and in worse case scenario , can I get my money back from the shipping company?

steve001 08-24-2014 01:51 PM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by ultimatekaiser (Post 1319368)
It's not wrong. I've asked. You can legally own them, and use them privately. But handhelds over class IIIa are not allowed for import or sale in the USA. I've been told this, both by customs and by the variance/ascession office.

Edit:
I do know that he's selling not buying, and it's only one, the rules are met as long as it is shipped with proper declaration, I see no issue. But that is how it is stated to me import wise. Export is fine, as it meets the standards necessary for the other country/buyer.

Show where it's the law >5mw handheld lasers meeting FDA standards can't be imported into the USA. A search does not indicate Congress has given the FDA that authority. Now all that matters is what the law says, not what individuals say.

mortuus 08-24-2014 03:57 PM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by EpicHam (Post 1319404)
So uh..... if it does get inspected and in worse case scenario , can I get my money back from the shipping company?

if you buy from laserbtb they offer that yes.

EpicHam 08-24-2014 04:03 PM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by mortuus (Post 1319430)
if you buy from laserbtb they offer that yes.

buying lasers on the internet just gets harder by the minute does it.

ultimatekaiser 08-24-2014 11:34 PM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by steve001 (Post 1319422)
Show where it's the law >5mw handheld lasers meeting FDA standards can't be imported into the USA. A search does not indicate Congress has given the FDA that authority. Now all that matters is what the law says, not what individuals say.

Aside from the fact that numerous people have been arrested and convicted of this, I think it is in the .11 but I'll check later. I've had this discussion elsewhere a few times. The last time I read them they haven't changed since August 1985, there are a few pending changes that aren't fully set in stone yet. Handheld lasers fit under demonstration lasers or SLA lasers depending on manufacturing intent. Both are limited to class IIIa or lower without a variance. (which are a pain in the ass to file by the way)

This has always been the rule it's just that they've always been so expensive, it's never been much of a problem. but with the price of laser technology dropping more, and more people being able to buy stuff at higher power, naturally the number of irresponsible users rises with it. Pointing them at planes and such and ruining it for us.

Don't get me wrong, that doesn't mean that I like it anymore than you do, or that you can't try to bend around the rules, etc... but that is what it says in writing, and anyone who breaks the rules has to be prepared for the potential consequences.

Similar laws are in place all around the world, Canada's in fact are almost identical to ours just limited to class II instead to general consumers. Believe me I've spent a lot of time researching on this as well as asking officially. I'm always open to a discussion about it though :) but lets not do it here.

Encap 08-25-2014 02:34 AM

Re: Help a newbie : US FDA Importation Requirements
 
Quote:

Originally Posted by steve001 (Post 1319422)
Show where it's the law >5mw handheld lasers meeting FDA standards can't be imported into the USA. A search does not indicate Congress has given the FDA that authority. Now all that matters is what the law says, not what individuals say.

Who do you imagine gave the FDA authority?

The FDA has the authority to regulate all kinds of lasers. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the agency regulates lasers used in medicine. And under the Electronic Product Radiation Control Provisions of the act, the FDA regulates both medical and nonmedical lasers such as those used to solder circuits in factories, to scan groceries in a supermarket, or to entertain a crowd with a light show in the night sky.

The FDA’s statutory authority to regulate these products is granted by the United States Federal, Food, Drug and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control. Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control

See: http://www.gpo.gov/fdsys/pkg/USCODE-...C-sec360oo.htm


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