Other company wants to use our FDA 510K bundled with their product

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#1
We are a class II medical device thermometer that broadcasts Bluetooth to our iPhone or Android phone application. Another company wants to bundle our device with their non-medical non-FDA product using their phone app to show the data.

I said we should perform a risk analysis for this along with validation testing and then ok it.

Comments?
 

Al Rosen

Staff member
Super Moderator
#2
The title of your post mentions bundling your 510k but your post doesn't describe the use of the 510k. If you reveal the details of your 510k, what's to prevent them from using your device as a predicate?
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#3
Not the 510K just the device. Its our device communicating using their interface.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
We are a class II medical device thermometer that broadcasts Bluetooth to our iPhone or Android phone application. Another company wants to bundle our device with their non-medical non-FDA product using their phone app to show the data.

I said we should perform a risk analysis for this along with validation testing and then ok it.

Comments?
Do you mean they want to buy your thermometer and then integrate it in their product (system) as a component, and on-sell?

What are you concerns? In the above scenario, it's going to be their responsibility. Yours will be limited to supplying a product according to the agreed spec. Any concerns of yours can be included in the supply agreement.
 


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