Does anybody have a succinct answer to the relationship between the FDA and 
safety approvals?

The FDA just seems to classify the maximum out of a laser component, and quite 
often is class III - and identifies it as harmful to the eye. If I use the 
device in a product then we have to be concerned with safety approvals of the 
requisite standard and they require class I output if the beam comes out of the 
enclosure. The FDA doesn't care about product standards other than medical 
standards.  UL will recognize a laser, imposing fault requirements that the FDA 
doesn't seem to impose, and will do an EN60825 evaluation as well. They do this 
with the help of the CDRH report filed with the FDA. Again they will classify 
the laser in alignment with the CDRH report, but the still apply the end 
product beam requirements. The FDA seems to care about classification and 
tracking of the device but not implementation. If class III is hazardous how 
does one make a gun sight laser for the commercial market without violating in 
the US or EU directives. I see a package marking that has the CE mark, but who 
can tell what that means without the DoC - could just be RoHS as far as I can 
tell.

Trying to get the program manager off my back - he's hell bent for leather - 
charging head because he found the gun sight on the market and that's enough 
for him. I don't actually blame him, but I need to understand the details a bit 
more than that.

I think I might be wrapped around the axel a little too tightly - the world is 
full of inherently dangerous things - guns and knives. Should I just be 
recommending that we grab any only FDA classified laser, put it in the product 
and sell it hither and yon, like a gun or a knife without product standards. 
How about the EU - just how does that work - I don't see any hint of a EU 
directive just the CE mark but without reference to directives. It could simply 
mean that they have RoHS.

Scans of the CDRH report requirements itself are helpful but don't address the 
relationship between FDA classification and safety control

Crud



Gary McInturff
Reliability/Compliance Engineer








Esterline Interface Technologies

Featuring
ADVANCED INPUT, MEMTRON, and LRE MEDICAL products



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