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 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
