Software as a Medical Device Accessory

[Dav949]

Hello All!! We have a Class II software platform and are going to be integrating it with some Class III devices. The software shows the incoming data (and can report and graph the data) and alerts the clinicians if the incoming data goes outside of the thresholds set by the clinicians. All the new devices we will be integrating are Class III FDA cleared devices. The changes we will need to make to our software platform will spark a new 510k. However, will this make our software then a class III?

 

[Mark Meer]

It is my understanding that yes, accessories take on the classification of their parent device.

From Content of a 510(k)

"Accessories to classified devices take on the same classification as the "parent" device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the "parent" device with the highest risk, i.e., class."

 

[Dav949]

Thank you