Re: FDA Approved Ultrasonic Equipment FCC Requirements for US sales
You may of course need an authoritative answer from a suitably knowledgable regulatory attorney. I can only provide comments based on my understanding.
As far as I know, 47 CFR (the legal basis for FCC actions) does not provide for exceptions based on either FDA jurisdiction or medical device usage.
The FCC is responsible for all electromagnetic-radiation-emitting activities that fall within its defined regulated spectrum bounds and received signal strength limits.
Note that their spectrum allocation chart includes the allocations for all military, space and household/consumer activities, which are otherwise subject to control and/or regulation by other governmental agencies.
If you are making a device that radiates sufficient power at a regulated frequency, my understanding would be that yes, it will be subject to FCC rules, irrespective of its FDA status or intended use.
Is there anything “official” that I can refer to which might give me the definitive “legal” answer?
You could try inquiring directly to the FCC:
[email protected], asking for a statement of jurisdictional scope.