I agree with gingeranderson, if we’re hypothetically talking about getting technology to the point where artificially grown organs are nearly indistinguishable from human organs, then it would fall under the responsibility of CBER to regulate these organs. However, I believe before we get to this end goal the government will have expanded this agency to cover more complex biologics. As it currently stands, CBER mainly reviews vaccines and blood components, nothing nearly as complex as a fully functioning organ. I’m skeptical we’ll ever get to the point where we can just buy pre-packaged ready-to-be-transplanted hearts, but if we do I believe, or at least hope, that our current infrastructure will have evolved with the technology.