Date Published: December 1, 2016
Publisher: Springer International Publishing
Author(s): Matthew Di Prima, James Coburn, David Hwang, Jennifer Kelly, Akm Khairuzzaman, Laura Ricles.
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.
Recently, additively manufactured/3D printed medical devices have caught the world’s attention: a 3D-printed bronchial splint saved a child’s life [1, 2], a 3D printed cranial plate replaced a large portion of a patient’s skull , a new artificial knee was personalized to fit the patient’s own anatomy , and a spine device was made with complex internal architecture which was previously impractical to produce . All of these are medical devices that have had profound effects on patient health and well-being. The FDA has been able to review and regulate these devices under existing regulations, by proactively identifying similarities with existing technologies and key differences that needed to be evaluated. For medical product production, additive manufacturing may offer an approach to make a device with complex architecture (e.g. integral porous coatings or internal lattice structure). Additionally, this technology has been leveraged to manufacture devices for specific patient’s anatomy (patient matching). While additive manufacturing of medical products has only recently entered the awareness of the mainstream media, the FDA’s Center for Device and Radiological Health (CDRH) has reviewed and cleared additively manufactured medical devices for more than 10 years. Over this time, there has been an increase in submissions utilizing this technology across a number of product areas; not just in medical devices but also including drugs and biologics. Recently, FDA’s Center for Drug Evaluation and Research (CDER) has approved a 3D printed drug and the Center for Biologics Evaluation and Research (CBER) has had interactions with stakeholders in the bioprinting field.
The FDA has continued its mission of ensuring patients and providers have access to safe and effective medical products while endeavoring to provide industry with a predictable, transparent and efficient regulatory pathway for additively manufactured devices. The Center for Drug Evaluation and Research approved the first 3D printed drug within the existing chemistry, manufacturing and control standards that all other drug products are regulated by. The Center for Devices and Radiological Health have cleared additively manufactured devices for over a decade within the existing medical device regulations. The Center for Biologics Evaluation and Research and the other Centers are following the literature closely and are interacting with stakeholders to ensure that US patients have access to innovative, safe and effective medical products as this technology expands.