Unified Device Identification Final Rule is out - September 2013

[Sam Lazzara]

You may find this link useful.

FDA's Medical Devices Product Code Classification Database

 

[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]

I would suggest to go through this video:
http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#software

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!

 

[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.