Unified Device Identification Final Rule is out - September 2013

S

ScottDL

I appreciate the help. I am also looking for a definition of what is (or is not) considered to be "Stand-alone software" as noted in section 801.50. We have a USB key that contains the software for our device that must be used in conjunction with the device like a key in the ignition of a car. Since it is really a part of the system I'm not sure if it would be considered to be "Stand-alone software" and have so far been unable to find a definition.
Thanks in advance,
Scott
 
sagai

sagai

Quite Involved in Discussions
I would suggest to go through this video:
(broken link removed)

That key is for me part of your device. Actually the USB stick raise some question whether or not the hardware is part of your device though ...
Cheers!
 
S

ScottDL

Thanks for the link. According to the video, the definition of "stand-alone software" is software that can be loaded on a typical generic computer to perform some type of medical device function. Therefore, I don't think it would apply to the software (USB) key that is a part of our overall medical device since the software only operates our unique device as part of the system.
 
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