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[Important] Legal Documents for a Product Consisting 5 mW Green Laser

greenlaserlover

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Good morning/afternoon/evening everyone.

I'm currently working on a project that consist 5 mW laser and let' say I want to enter US market, do I need any legal certificate for this product? I read the legal document provided from laserpointersafety.com but I couldn't figure it out clearly. Any help is appreciated.

-Lasers will not be produced by me I will buy it so laser will have the certificate but do I need it?
 



RedCowboy

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I expect you will need your device/product to be certified and you are required to submit a radiation emission report to the FDA in some cases ( I'm no expert ).......also I know it will have to display a sticker denoting the laser class and that it complies with the applicable laws along with other likely required information........I see that on any commercial product with a laser under 5mw incorporated.....under 5mw a sticker might be all you need but I don't know that so do some research.

That said a product liability lawyer should be consulted, I doubt that any advise found in a forum can protect you from legal liability and how would you know ?

Here you go, read this > https://www.fda.gov/industry/fda-esubmitter/radiological-health-program

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greenlaserlover

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I found a document FDA 3632 (8/17) I think it should be filled but didn't encountered the sticker you send, thanks.
 

RedCowboy

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Actually you may want to start here. Under 5mw may only need a sticker but I am not sure.


Here's some more.......someone else here can tell you better what is required........maybe just a sticker and a test report of your product, but again I don't know, kind of curious myself now.


Getting closer lol


Ge whiz, government makes nothing simple huh.....

 
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Encap

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Pretty clearly you don't know what you are doing with regards to FDA laser Laws, rules, and regulations.
Yes, you need to comply with all FDA laser Laws, rules, and regulations. There are several steps involved, not just obtaining one "certificate" like in some Countries, if you want to comply, import,and resell in the USA.

You would be much better off consulting an expert or a firm who is expert in complying with the FDA requirements and know what they are doing and how to do same. Is a complicated and large set of laws, rules, and regulations.
Nobody on LPF is going to be able to tell you or walk you through all that has to be done or even know comprehensively and clearly all that is required and has to be done.

LPF is a laser hobbyist web forum --not an FDA compliance site nor a guidance site for laser manufacturing, importing, and reselling.

Where are you? What Country are you in. What is it that you want to do? Buy, import, and resell a laser pointer 5mW or less? Buy, import and resell some other device that a 5mW or less laser is a component part of? Do you want to start a business and be the manufacturer, importer and resell from within the USA to customers in the USA as a commercial business?

Talk with your envisioned/proposed manufacturer and ask if the product you want to buy complies with all USA FDA laser laws, rules, and regulations and ask them to provide proof of same.
It is the manufacturers responsibility to comply with all the FDA laws, rules, and regulations not your responsibility unless the manufacturer does not do the required FDA compliance work, then you would be seen as the manufacturer for compliance purposes.
Note: "manufacturer" for FDA and laser regulation purposes means " A manufacturer is any person or organization in the business of making, assembling, importing [1000.3(f)], or modifying laser products [1040.10(i)]. " from Compliance Guide below.

See FDA Compliance Guide for Laser Products here: https://www.fda.gov/media/74026/download

Here is a list of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
Import Alert 95-4: https://www.accessdata.fda.gov/cms_ia/importalert_254.html

You need to talk with FDA CDRH and have them tell you what you need to do to be in comp0liance with FDA law, rues, and regulations see: https://www.fda.gov/radiation-emitting-products

Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
DICE@fda.hhs.gov
(800) 638-2041
(301) 796-7100
 
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