I don't know.  That's a very interesting question. 

For each separate title in the CFRs there's a 
separate federal enforcement agency. 
CFR Title 47 Telecommunications is the FCC. 
CFR Title 29 Labor (or workplace stuff) is OSHA, etc ... 
and thus CFR Title 21 Food and Drugs is FDA. 

That's what happens when new laws come into 
effect - they try to determine if an enforcement 
agency already exists.  If there is none, then they 
have to start up a whole new agency. That's why 
the FCC was started (as were others) when the 
law was passed regarding telecommunications. 
So that's why CFR Title 47 is FCC country and 
CFR Title 21 is FDA country and the two don't mix. 

Keep in mind that although the laser laws are 
obviously written for laser safety, much of it is 
actually for the medical field as well as experimental 
scientific stuff where the potential for immediate 
and permanent harm is present. 

The OSHA requirement specifically addresses 
equipment being approved by an NRTL. But, 
with laser products and systems, you apply to 
the FDA. The FDA is not an NRTL. And it 
will never be since NRTLs are approved by 
OSHA.  The FDA and OSHA are enforcement 
federal agencies in parallel with each other and 
don'tapprove each other's methods. 

And you get nothing back from the FDA except some 
letter acknowledging your submittal.  Nothing else. 
There's no "approval" to speak of.  Certainly if you 
misrepresent your laser product or system and some 
unfortunate incident were to happen, you would most 
likely be charged with something from the FDA itself. 
But not limited to the FDA. 

The radiological side of things are also touched on 
by something like 1950 which probably does borrow 
from the FDA.  And since 1950 is used by NRTLs 
for product compliance, maybe that's how OSHA 
might also get involved. 

It sounds as though if you're unfortunate to have 
some accident befall you, you could potentially get 
multiple hits from several different federal agencies. 

I don't know Jeff.  Like to hear the others about this. 

Regards, Doug McKean 



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