Author/Authors :
Di Prima, Matthew US Food and Drug Administration - Center for Device and Radiological Health - Silver Spring - MD , USA , Coburn, James US Food and Drug Administration - Center for Device and Radiological Health - Silver Spring - MD , USA , Hwang, David US Food and Drug Administration - Center for Device and Radiological Health - Silver Spring - MD , USA , Kelly, Jennifer US Food and Drug Administration - Center for Device and Radiological Health - Silver Spring - MD , USA , Khairuzzaman, Akm US Food and Drug Administration - Center for Drug Evaluation and Research - Silver Spring - MD , USA , Ricles, Laura US Food and Drug Administration - Center for Biologics Evaluation and Research - Silver Spring - MD , USA
Abstract :
Additive manufacturing/3D printing of medical devices is becoming more commonplace, a 3D printed drug is now
commercially available, and bioprinting is poised to transition from laboratory to market. Despite the variety of
technologies enabling these products, the US Food and Drug Administration (FDA) is charged with protecting and
promoting the public health by ensuring these products are safe and effective. To that end, we are presenting the
FDA’s current perspective on additive manufacturing/3D printing of medical products ranging from those regulated by
the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the
Center for Biologics Evaluation and Research (CBER). Each Center presents an overview of the additively manufactured
products in their area and the specific concerns and thoughts on using this technology in those product spaces.
Keywords :
Additively manufactured , medical products – the FDA perspective , FDA , CDER , CDRH , Additive manufacturing/3D printing
