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.
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.
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.
