FDA classification and registration for a software plugin

[jayquality]

Hi all,

Here's the situation.
Our company makes a medical device class I, FDA registered, successfully inspected by them too. A Plantar pressure measurement device.
Device is hardware plus user software to visualize measurement results.
We have a sister company who built a software plugin module for our software that uses the results to make calculation for orthotic supports (their business).
Now the question, how should they register the software plugin with the FDA?
Classification I would say class I, same as the base system.
The plugin cannot operate without our device and software but how to define that?


tx for any advice

 

[yodon]

Can you clarify what the plugin does? Is it just for presentation via a browser? Is it the only means to present the results of the software calculations?

 

[jayquality]

The main software measures plantar pressures and calculates a number of parameters, the plug in uses this data to calculate the support corrections needed to make a custom orthotic support.
The plugin is transparent and seamless to the user, it adds another screen that shows the orthotic and corrections for the measurement, Data can then be sent via internet to the company for processing into a orthotic support.
Basically the software and plugin are written by the same guy but since they are marketed by 2 different companies each has to take responsibility for their parts.