text: The current American regulation for organ matching is centered on the national registry of organ donors after the National Organ Transplant Act was passed in 1984. This act was set in place to ensure equal and honest distribution, although it has been proven insufficient due to the large demand for organ transplants. Organ printing can assist in diminishing the imbalance between supply and demand by printing patient-specific organ replacements, all of which is unfeasible without regulation. The Food and Drug Administration (FDA) is responsible for regulation of biologics, devices, and drugs in the United States. Due to the complexity of this therapeutic approach, the location of organ printing on the spectrum has not been discerned. Studies have characterized printed organs as multi-functional combination products, meaning they fall between the biologics and devices sectors of the FDA; this leads to more extensive processes for review and approval.  In 2016, the FDA issued draft guidance on the Technical Considerations for Additive Manufactured Devices and is currently evaluating new submissions for 3D printed devices. However, the technology itself is not advanced enough for the FDA to mainstream it directly. Currently, the 3D printers, rather than the finished products, are the main focus in safety and efficacy evaluations in order to standardize the technology for personalized treatment approaches. From a global perspective, only South Korea and Japan's medical device regulation administrations have provided guidelines that are applicable to 3D bio-printing.
  There are also concerns with intellectual property and ownership. These can have a large impact on more consequential matters such as piracy, quality control for manufacturing, and unauthorized use on the black market.  These considerations are focused more on the materials and fabrication processes; they are more extensively explained in the legal aspects subsection of 3D printing.