Does FDA allow comparing with the competitors Medical Device

[noorain]

Does FDA allow, company to purchase competitors device for RnD purpose?

 

[Ajit Basrur]

Yes you can analyze the competitor product for initial research and the design inputs stage. If your device is a Class II, you could also do a substantial equivalence to a predicate product.

Also refer an existing thread, Buying a competitors product for SE testing

 

[invitro_spain]

Yes, of course. If you are thinking to submit a 510k and you have selected a competitor's device as your predicate; you have to use it during your performance testing and method comparison studies.

 

[MasterBB]

Yes, Of course... It is a MUST if you want to understand the competition as well as leap frog.