Additively manufactured medical products – the FDA perspective

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.

3D printed renal cancer models derived from MRI data: application in pre-surgical planning

“…Certifying the accuracy of 3D printers is however out of the realm of the FDA [17]. It is important to ensure the accuracy of 3D printed medical models.…”

Logistics of Three-dimensional Printing

“…Unlike 3D models used for educational purposes, those used for surgical planning must be available on a reliable schedule, and sometimes with relatively short turn-around times. Attaining an acceptable level of reliability may require more printers and service contracts on those printers, to hire multiple full-time staff, and to set up schedules so that the clinical needs can be met (5, 6). With sufficient clinical need, an alternative policy for outsourcing printing of these models may be needed, if in-house personnel and equipment cannot meet the need.…”

Impact of Three-Dimensional Printing on the Study and Treatment of Congenital Heart Disease

“…While open-source options exist, they have a steep learning curve. Factors that mitigate start-up costs include innovations from the open source community and the fact that the FDA does not provide oversight for the production or use of patient-specific models when used as a visual aid (10). …”