The FDA (Food and Drug Administration in the United States) and your Laser

[Walt Langhans]

Hi Everyone,

So after I found out that my laser was being held up by the FDA today I decided to do a little digging I came across this on their web page:

What is FDA’s role in regulating lasers?The FDA regulates both medical and non-medical lasers. The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a show so that the agency can inspect it if possible and take action if required.
FDA is currently working to identify manufacturers of overpowered green laser pointers and other illegal lasers, and is taking action to prevent these unsafe products from being sold in the United States.

Hun... who knew? But I suppose that's better than just having a department of Lasers, although if we did it might be neat to work there, but then again probably not so much...

[Richard Rumancik]

It's actually the CDRH within the FDA that monitors/regulates laser use. How this came to be is probably rather convoluted. The FDA (Food and Drug) Administration somehow gained control of medical devices - since medical devices are related to drugs, in that they cure illnesses. And lasers are used in medical devices. Thus, the CDRH regulates the use of lasers. But wait - lasers are also used to engrave and cut. The bottom line is that the FDA regulates the use of the laser in your laser engraver and the safety thereof. Seems to me it might have been more appropriate to give the jurisdiction over cutting equipment to UL in the US (or other agencies like CSA in Canada and IEC in Europe) but that is the way it is regulated at the moment. Seems like the CDRH also regulates microwave ovens due to possibility of emissions.

[Lucy Lee]

Hi Walt,
it is becuas of laser ,cuase they think the laser with radiation ,so if with FDA certificate, then means it is safe, is this to your question?And we have FDA certificate, if you need ,just ask me freely

Best Regards
Lucy Lee


Hi Everyone,

So after I found out that my laser was being held up by the FDA today I decided to do a little digging I came across this on their web page:

What is FDA’s role in regulating lasers?

The FDA regulates both medical and non-medical lasers. The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a show so that the agency can inspect it if possible and take action if required.
FDA is currently working to identify manufacturers of overpowered green laser pointers and other illegal lasers, and is taking action to prevent these unsafe products from being sold in the United States.

Hun... who knew? But I suppose that's better than just having a department of Lasers, although if we did it might be neat to work there, but then again probably not so much...

[Jason Roehl]

It's actually the CDRH within the FDA that monitors/regulates laser use. How this came to be is probably rather convoluted. The FDA (Food and Drug) Administration somehow gained control of medical devices - since medical devices are related to drugs, in that they cure illnesses. And lasers are used in medical devices. Thus, the CDRH regulates the use of lasers. But wait - lasers are also used to engrave and cut. The bottom line is that the FDA regulates the use of the laser in your laser engraver and the safety thereof. Seems to me it might have been more appropriate to give the jurisdiction over cutting equipment to UL in the US (or other agencies like CSA in Canada and IEC in Europe) but that is the way it is regulated at the moment. Seems like the CDRH also regulates microwave ovens due to possibility of emissions.

Underwriters Laboratories (UL) is a private organization--manufacturers pay to have their products tested to be able to use the UL logo, so I would not be in favor of giving them "jurisdiction". Not that I'm a fan of the (over) reach of the FDA, either...

[Walt Langhans]

@ Richard, you should write for the government. You pretty much summed up what it took them about 3 pages to say !

@ Lucy, it wasn't really a question as much as a statement of surprise to find out that the FDA has anything to do with lasers. But as always thanks for the info :) As other have pointed out, in the warped way that our government works some times it kind of make sense. You know, in a if you look at it sideways while standing on your head kind of way sense

[Mike Null]

Hey all, we keep a tight rein on political comments here as they never fail to ignite emotional outbursts. Walt's remark was very mild but could be the spark.

[ray hampton]

[QUOTE=Walt Langhans;2036824]@ Richard, you should write for the government. You pretty much summed up what it took them about 3 pages to say !

three pages, by the time that I read half of the first page , will need to read the first of the page again, will read three pages maybe ten times before I finish

[Mike vonBuelow]

I thought this thread was going to be about those youtube videos of people cutting food with their laser

[Kim Vellore]

FDA has control on what is being imported to the US and UL is just an compliance specifically to electrical standards and not laser safety. We buy big lasers for the systems we build and FDA wanted covers on the laser output for safety. So the manufacturer installed a red cap on the output which we discard after we get it. This red cover will be blown out if the laser is turned ON with the cover. It is one of the silly rules we have to adhere to, if we are to import lasers from outside the US. We can however manufacture and ship it without this cover.

Kim

[Stan Lightner]

This is one example of why it can be to one's advantage to purchase items made in your own country if at all possible. While I'm fairly certain the imported laser costs less than a domestic one, this delay is certainly costing you business that can never be replaced. Other factors such as the availability of tech support, parts when needed and numerous other issues can arise that will drive up the full cost of ownership of the imported laser.

Consequently when making substantial capital investments one needs to look at the long term cost, not just the immediate dollar amount.

[Jerome Stanek]

When I said that you need to check to see if the laser you are looking to get from China to make sure it is FDA approved people said I didn't know what I was talking about. They told me that it would be the fcc that you need to worry about. Maybe now they will listen

[Mark Ross]

The FCC is also involved. I don't know the lower end of the frequency, but anything that operates at a certain frequency and plugs into AC mains has to prove that they do not generate (radiate) noise that goes back on the AC line (CISPR Quasi Peak). If your customs inspector is sharp, they can make you prove this, I have had it happen on test equipment.

You also have IEC 60825 which covers laser safety. Depending on the country of import they could demand this as well. A CE mark is an absolute joke as it is "self certifying" so anyone can throw a CE mark on a product with little or no ramification. Throwing a UL mark on a non UL product is another thing, but it happens all the time with counterfeits.

[Walt Langhans]

Everything has been handled. The Shenhui lasers are in compliance with all the US standards, the FDA just need the number that they had issued to Shenhui that proved they where in compliance. (Not sure why they didn't have it since they issued it, but what ever). This little hold up has not caused any issues my business because I planed for longer delays so all is well.