Packaging device with accessories already on the market

#1
Hello everyone,

My client is interested in placing a Class II device on the market as a standalone device. This device requires accessories to be used at the end user. Because of the pandemic, the users (hospitals) are having difficulty obtaining the accessories needed in a timely manner.
They are now considering sending a final package to the hospital with the accessories included. They are interested in marketing this in India but are also interested in FDA clearance.

I have a few questions:
1) Do they need a distributor type arrangement with the accessories manufacturers?
2) Can the device still be filed as a standalone or will it now need to be treated as a system with the accessories as components?

Thank you in advance for weighing in!
 
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