Compatibility of a Class II exempted accessory with a Class III device

C

Corax

#1
Help - I'm confused in this matter!

We manufature FDA Class II exempted devices (MDD class IIa) and have an accessory for these devices that can changes a limited amount of settings within the main device - like a remote control with limited possibilities.

A company within the same Holding company manufactures class III implant devices.
They would like to state compatibility with our accessory meaning the accessory would have similar limited remote control possibility for their device - but would this make the accessory a class III device?

We would not change our labeling or intended use - the device would be sold as is (class II exempted). And we would not claim the compatibility.

They would not claim that this is an accessory to their device and would not sell our accessory, only state compatiblity and ensure proper compatibility testing as well as incorporate the compatibility with our accessory in their risk management.

How does this setup sound to you?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Their PMA will have to support/defend their direct compatibility claim and implied safety and efficacy claim by means of evidence.

The classification of your device as you sell it won't change. It however will have to be evaluated to Class III standards by them.

They would not claim that this is an accessory to their device [...] only state compatiblity
The latter has the same meaning as the former.
 
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