Hi.. this is very helpful. I have a question - For demonstrating substantial equivalence can we consider devices with different materials such as in Titanium versus Polymer. Both are biocompatible and achieve same intended purpose, but through a different material. Will it be accepted by TGA? Thanks!
Just my two cents, you will need to demonstrate the equivalence in biological (through biocompatibility test and/or chemical characterization test), mechanical (mechanical testing), and some other relevant tests (e.g., does it carry cellular or animal components?) between these two materials to show that they are equivalent in safety and performance for the intended purpose.
Hi.. this is very helpful. I have a question - For demonstrating substantial equivalence can we consider devices with different materials such as in Titanium versus Polymer. Both are biocompatible and achieve same intended purpose, but through a different material. Will it be accepted by TGA? Thanks!
Just my two cents, you will need to demonstrate the equivalence in biological (through biocompatibility test and/or chemical characterization test), mechanical (mechanical testing), and some other relevant tests (e.g., does it carry cellular or animal components?) between these two materials to show that they are equivalent in safety and performance for the intended purpose.