If your device contains communication radios within the device, i.e., part of the device functionality you will need to do an assessment to the FCC regulations in the USA. What determines the process is the radio/transmitters spectrum use. An active medical device that transmits data via Bluetooth and Wi-Fi normally falls under PART 95 (FCC) but it is dependent on the frequency band used by the transmitter/radio. For example 175kHz radios which are also used in active implantable device may only require a supplier DoC. THis type of radio will be measured for radiated power level against the general requirement in Par 15.209 to ensure the radiated field is low enough to allow for FCC verification instead of certification (requires a submission to FCC). Bluetooth components do not fall into this category, however keep in mind some devices may have both types of radios, depending on the intended use/device description/functionality.
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[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[
mmontanez@namsa.com]
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Original Message:
Sent: 28-Feb-2022 02:36
From: Assaf Yichia
Subject: FCC compliance
Our product is Class II implantable device which has RF communication method.
Do we need to be FCC compliance in addition to 21 CFR part 820?
Thanks
Assaf Yichia
QA Manager
Microbot Medical
O: +972-4-8200710
M: +972-52-2048535
E: assafy@microbotmedical.com
W: www.microbotmedical.com
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