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Subsection of applications in terms of surgical/training use for doctors: Add more

Surgical usage of 3D printing has evolved from printing surgical instrumentation to the development of patient-specific technologies for total joint replacements, dental implants, and hearing aids. In the field of organ printing, there is an extensive breadth of applications for patients and surgeons. For instance, printed organs have been used to model structure and injury to better understand the anatomy and discuss a treatment regime. For these cases, the functionality of the organ is not required and is used for proof-of-concept. These model organs may provide advancement for improving surgical techniques, training inexperienced surgeons, and moving towards patient-specific treatments.

Legal and Safety
3D-printing techniques have been used in a variety of industries for the overall goal of fabricating a product. Organ printing, on the other hand, is a novel industry that utilizes biological components to develop therapeutic applications for organ transplants. Due to the increased interest in this field, the regulation and ethical considerations are in desperate need to be established. With the potential to revolutionize medicine, there can be legal complications from pre-clinical to clinical translation for this treatment method.

Regulation
The current 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 to diminish 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, where organ printing falls 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 In 2016, the FDA issued draft guidance on the Technical Considerations for Additive Manufactured Devices and is currently evaluating new submissions for 3D printed devices.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 may not be advanced enough for the FDA to mainstream it directly. Currently, the 3D printers, rather than the finished products, are the main focus on what is being evaluated for safety and efficacy 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.

Outside of legal authority, there are also potential concerns about patent control. 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.

Ethical Considerations
On an ethical standpoint, there are concerns in respect to the availability of organ printing technologies, the cell sources, and public expectations. Although this novel approach may be less expensive than traditional surgical transplantation, there is skepticism in regards to social availability of these 3D printed organs. Contemporary research has found that there is potential social stratification for the wealthier population to have access to this therapy while the general population remains on the organ registry. The cell sources mentioned previously also need to be considered. Organ printing has the potential for eliminating animal studies and trials, but also raises questions on the ethical implications of autologous and allogenic sources. More specifically, studies have begun to examine future risks for humans undergoing experimental testing. Generally, this application can give rise to social, cultural, and religious differences, making it more difficult for worldwide integration and regulation. Overall, the ethical considerations of organ printing are similar to those of general Ethics of bioprinting, but are extrapolated from tissue to organ. Altogether, organ printing provides large scale health benefits for patients and surgeons, but there are short- and long-term legal and ethical consequences that need to be considered before mainstream production can be feasible.