THE EMERGENCE OF “NEW” ORGANS: A PROPOSAL TO REGULATE BIOPRINTING TECHNOLOGY UNDER THE MEDICAL DEVICE FRAMEWORK
Organ bioprinting involves using cells and biomaterials to 3D print structures that resemble and imitate the functions of natural organs. Since bioprinting is a relatively new technological advancement, there is a lack of regulatory structure in the United States, despite regulatory structures around the globe that are more developed in this field. Because of bioprinting’s potential utility, a regulatory structure to ensure the efficacy and saftey of bioprinted organs is needed.
The two potentially available regulatory frameworks to cover bioprinting technology in the United States are biological product and drug regulations and medical device regulations. Bioprinting does not fit neatly in either regulatory framework because bioprinted products contain elements of both medical devices and biologicals-they are “combination products.” Selecting the proper regulatory framework is vital because of the ethical considerations and potential saftey risks of this technology. The Class III medical device regulatory framework is best suited to regulate bioprinting technology as its requirements will ensure bioprinting’s safe usage and will not stifle the growth of bioprinting technology.
Author: Brooke Siegal
PDF: http://ncjolt.org/wp-content/uploads/sites/4/2023/05/Siegal-Final.pdf
Volume 24, Issue 4