Including two Class 1 Medical Devices as one 'promo' item

ThasYuwa

Inactive Registered Visitor
#1
Greetings everyone,
One of my clients have two Class-1 medical devices (say, devices A and B) listed with the FDA. What additional hurdles do they have to overcome to bundle the two devices under one trade name (say, C)?
More related info:
- the intended use for A and B will not change even when sold as C.
- the client wishes to continue to sell A and B as separate devices as well.

Is 'C' considered a bundle? I realize bundling is not a favorable path when submitting 510k's. But I'm not sure about the implications when A and B are already listed with the FDA. Is there a specific group within FDA who can answer this?
Any and all help will be much appreciated.
 
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isoalchemist

#3
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:2cents: You might want to start with these guys and let them redirect you. They might want a bit more clarity which understandably would not be shared in an open forum. Gut instinct is you would at minimum need to list it as Product C if the name is unique, but would need more information to even try to think through it.
 
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