Medical Device Wireless Labeling Requirements

J

jessglud

#1
We are including wireless technology within our class II medical device. What are the labeling requirements? The wireless card we are purchasing is off-the-shelf and comes with an FCC ID. The question is do we have to place that on the system, and if so does it have to be prominent?

Any help would be appreciated.
 
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R

rgs-info

#2
That's a bit delicate. CDRH will likely require the labeling to discuss the technology used, recommendations to the client for handling security, network integrity & interruptions, etc.

At the end, you want to tell your users exactly what's being used, and what they can do to best ensure that the network connections are reliable. Also, you'll need to outline their responsbilities regarding what security settings to use, how to minimize interference, and how to test that it works properly in their environment (in a variety of situations) before moving it into production or live use.
 
R

rgs-info

#3
This is a separate issue, but for a recent 510(k) submission I worked on, we also created a wireless hazard analysis document, to clearly show what hazards we considered related to wireless use of the device, and how each of those were mitigated - either in the design or the labeling.

This proved to a great aid in helping FDA understand how the device was used, and the role wireless played in that use. It also showed that we had thought thru the issues related to wireless and had them addressed appropriately.
 
W

wangyang

#4
If you have to print the FCC id of the component(wireless card) to the system? my answer is no, i think maybe you have to test the entire system according to FCC regulation, and decide what kind of labeling requirement to follow.
 
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