FDA Approved Ultrasonic Equipment - FCC Requirements for US sales

C

Cassis

#1
If a device is FDA approved and is also an intential radiator (i.e., ultrasonic equipment), must it also be compliant with FCC rules (Part 18) in order for it to be sold in the US?
Many thanks for any help you may be able to offer!
 
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M

MIREGMGR

#2
Re: FCC requirements for US sales

Ultrasound is acoustical energy. The FCC regulates electromagnetic energy.

If however your example were a medical device that is likely to emit electromagnetic energy within the regulated frequency range at a regulated power level, then yes, that medical device would have to meet both FDA and FCC regulatory requirements.

Diathermy of the so-called shortwave type is an example of a medical technology that is subject to both regulatory bodies.

In the US and most of the rest of the world, all uses of the RF spectrum are subject to a grand allocation scheme, which can be found online in various places. RF diathermy machines, for instance, all operate within a spectral allocation assigned to them. It would be highly irregular to design RF-emitting equipment without advance planning as to the frequency to be used, the legal appropriateness of that frequency for that use, and whether there might be conflicting uses.
 
C

Cassis

#3
Re: FDA Approved Ultrasonic Equipment FCC Requirements for US sales

Thank you very much for your helpful reply MIREGMGR.

I wonder whether you might be able to clarify a little bit. Putting my question another way: does the FCC have jurisdiction over medical devices? For example, let’s say an ultrasound device complies with IEC 60601-1-2 (Class A Equipment) and is FDA approved. However, the Part 18 FCC requirements are more stringent than the IEC standard (their requirements are more on the level of Class B equipment for ultrasound devices - something that has changed in the past years, it used to be less stringent!) and thus this device may not necessarily comply with Part 18, even though it meets the IEC 60601-1-2 EMC standard. Must this device also comply with Part 18 FCC in order to sell the device in the US? Isn’t it sufficient to have FDA approval? I have looked around and tried to find an official statement from the FDA or from FCC regarding this question and haven’t had much success. Our notified body referred us to our EMC lab, and different EMC labs seem to give varying answers. Is there anything “official” that I can refer to which might give me the definitive “legal” answer?

Thank you again!!
 
M

MIREGMGR

#4
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.
 
C

Cassis

#5
Re: FDA Approved Ultrasonic Equipment FCC Requirements for US sales

Thank you very much, it seems wise to seek some legal counsel, which is where we are heading now.
 
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