R
Reinheitsgebot
Does anyone have a view on the correct classification of a spring-driven autoinjector under HC classification rules?
My reading at the moment is that probably Rule 11 for active devices intended to administer drugs applies, which makes the autoinjector a Class II device.
The autoinjector is primed by manually pushing back on an internal spring mechanism, then a pre-filled standard piston syringe is placed in the autoinjector. On activating the autoinjector the spring mechanism pushes on the syringe plunger to deliver the drug injection.
My thinking is that the stored energy of the spring mechanism, albeit manually primed, makes the autoinjector an active device.
For reference the US FDA classification of this device would be Product Code KZH, Regulation Name: Syringe Needle Introducer.
Many thanks for any advice or comments!
My reading at the moment is that probably Rule 11 for active devices intended to administer drugs applies, which makes the autoinjector a Class II device.
The autoinjector is primed by manually pushing back on an internal spring mechanism, then a pre-filled standard piston syringe is placed in the autoinjector. On activating the autoinjector the spring mechanism pushes on the syringe plunger to deliver the drug injection.
My thinking is that the stored energy of the spring mechanism, albeit manually primed, makes the autoinjector an active device.
For reference the US FDA classification of this device would be Product Code KZH, Regulation Name: Syringe Needle Introducer.
Many thanks for any advice or comments!