I believe it would be under the CBER because it would be tissue (I’m assuming an artificially grown organ would be nearly identical to our actual organs). Tissue and blood would be under CBER. I believe the process of approval would be IND, (Phase 1,2,3) or Pivotal Trials, BLA as outlined in lecture.

If the organ is under the CDRH, one might even go as far to call it a combination product depending if the organ such as a heart already had some blood in it when the surgeon implants it in the patient. This would call for a RFD. The entire point of an RFD is to determine exactly where a product falls and would be the formality to ensure it doesn’t end up under the wrong category with the wrong approval pathway. “By submitting a “Request for Designation” (RFD), a company may obtain a formal agency determination of a combination product’s primary mode of action and of assignment of the lead agency center for the product’s premarket review and regulation, or of the agency component that will have jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute”

http://www.fda.gov/CombinationProducts/RFDProcess/