Three important regulatory milestones should be acknowledged. This change, and the role of the radiologist as a central facilitator of these services, opens discussion about topics ranging from clinical uses to patient safety to regulatory implications. ![]() ![]() An important shift is happening towards point-of-care manufacturing for medical models in a hospital environment. For these procedures, the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has reviewed and cleared 3D printed medical devices for more than 10 years. Food and Drug Administration (FDA) to empower healthcare providers with innovative, personalized devices that are safe and effective, while academicians have devised and tested new interventions that would not be possible without 3D printing. Medical device manufacturers and individual industry leaders have worked with the U.S. Although this growth has provided an appearance that the medical modeling application is nascent, 3D printing for surgical planning and the use of 3D printing to develop tools to enhance medical procedures has a rich history in both private practice and academic medicine. 3D printing from volumetric medical images has entered a phase of steep growth.
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