FCC Rules for Hospital Wireless Medical Devices

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bio_subbu

Super Moderator
#4
The FCC doesn't regulate devices per se, rather they regulate the portions of the radio spectrum in which they operate, or only how it might operate in a specific portion of the radio spectrum. It is up the manufacturer of the medical device to determine which frequency to use and their choice of frequency will determine which of the FCC's rules will apply.
 

Al Rosen

Staff member
Super Moderator
#5
The FCC doesn't regulate devices per se, rather they regulate the portions of the radio spectrum in which they operate, or only how it might operate in a specific portion of the radio spectrum. It is up the manufacturer of the medical device to determine which frequency to use and their choice of frequency will determine which of the FCC's rules will apply.
Unless you are applying for a license, part 15 applies. Do you know of any medical devices which require a license from the FCC to operate?
 

bio_subbu

Super Moderator
#6
Unless you are applying for a license, part 15 applies. Do you know of any medical devices which require a license from the FCC to operate?
I request you to refer below link to find all applicable rules and regulations for the FCC.

http://www.access.gpo.gov/nara/cfr/waisidx_09/47cfrv1_09.html

Every radio module operating under the Part 15 rules must be tested and approved by the FCC before being marketed in the US. If the manufacturer designs the radio module for the medical device, the manufacturer needs to test the radio and submit the results to the FCC for approval.
 
M

mr.mike

#7
Thanks for this.
It is a "draft guidance" though, no? Each page states "Draft - Not for Implementation".
...as such, how valid are these guidelines?
 
S

singber

#8
My company had to follow the recommendations in the above guidance during a recent 510(k) submission for a device that operated on a wireless handheld computer.

We were basically told if we didn't, the device wouldn't be cleared.
 
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