Doubts about the FCC regulations for the use of Bluetooth in medical equipment

everq32

Starting to get Involved
#1
Hello.
I am currently working in a Startup where we are developing a medical device wearable type. I have doubts about the FCC rules about the use of Bluetooth.
The device is expected to be commercialized in the USA market.
Basically the device consists of 2 PCB one is a module made by another manufacturer, this has the processor and a ufl connector for bluetooth or Wi-Fi connectivity. We will add a chip type antenna on the board base and a connection will be used through a ufl to ufl cable of female type.
My big question is this: You must start the whole certification process for the bluetooth antenna that is going to be implemented. If so, what are the rules or sections on which I must base my design?
I do not have much experience with the use of regulations and I would appreciate any guidance you can give me.
Thank you very much.
 
Last edited by a moderator:

Al Rosen

Super Moderator
Staff member
Super Moderator
#2
Hello.
I am currently working in a Startup where we are developing a medical device wearable type. I have doubts about the FFC rules about the use of Bluetooth.
The device is expected to be commercialized in the USA market.
Basically the device consists of 2 PCB one is a module made by another manufacturer, this has the processor and a ufl connector for bluetooth or Wi-Fi connectivity. We will add a chip type antenna on the board base and a connection will be used through a ufl to ufl cable of female type.
My big question is this: You must start the whole certification process for the bluetooth antenna that is going to be implemented. If so, what are the rules or sections on which I must base my design?
I do not have much experience with the use of regulations and I would appreciate any guidance you can give me.
Thank you very much.

Start with 47 CFR part 15 which governs unlicensed transmissions.
 
Last edited:

Mark Meer

Trusted Information Resource
Trusted
#4
It is also very helpful to seek advice from 3rd party test labs. They will be experienced in FCC requirements, and can often even complete the grant application on your behalf.

If you are planning to have the wireless portions tested by a test-lab, reach out to them early. Describe your product in detail, and they should be able to tell you what tests are required for an FCC grant.
 
Top