For the case of the syringe, it would depend on the interaction with the body. I think that would have rather large implications and would dictate the various routes that may have to be pursued. For the syringe, the plastic portion would not come in direct contact with the body per se so I do not believe the product would have to be reclassified as a result.That is if we are going from plastic A to B but both have been used in the past. In regards to using a completely new plastic material that has not be used before, there would have to be extensive bio-compatibility studies performed depending on the interaction the material have with the human body. There can be equivalency studies performed to show how plastic A for example has similar characteristics to the new plastic to keep the classification as class II device. However, if the composition of the plastic itself is completely novel then I believe one would have to the PMA route since there would be no precedent in the past. There would have to be extensive testing performed from probably an animal study to clinical study route.