U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, Silver Spring, MD 20993, USA.
U.S. Food and Drug Administration, Office of the Commissioner, Commissioner's Fellowship Program, Silver Spring, MD 20993, USA.
Sci Transl Med. 2018 Oct 3;10(461). doi: 10.1126/scitranslmed.aan6521.
Additive manufacturing [also known as three-dimensional (3D) printing] is the layer-wise deposition of material to produce a 3D object. This rapidly emerging technology has the potential to produce new medical products with unprecedented structural and functional designs. Here, we describe the U.S. regulatory landscape of additive manufactured (3D-printed) medical devices and biologics and highlight key challenges and considerations.
增材制造[也称为三维（3D）打印]是通过逐层堆积材料来生产三维物体的技术。这项快速发展的技术具有生产具有前所未有结构和功能设计的新型医疗产品的潜力。在这里，我们描述了美国监管环境下的增材制造（3D 打印）医疗器械和生物制品，并强调了关键的挑战和考虑因素。
