Additively manufactured medical products – the FDA perspective
Journal Title: 3D Printing in Medicine - Year 2016, Vol 2, Issue
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.
Authors and Affiliations
Matthew Di Prima, James Coburn, David Hwang, Jennifer Kelly, Akm Khairuzzaman, Laura Ricles
Keywords
Related Articles
- EP ID EP680667
- DOI 10.1186/s41205-016-0005-9
- Views 45
- Downloads 0
Low-cost customized cranioplasty using a 3D digital printing model: a case report
Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
Customized tracheal design using 3D printing of a polymer hydrogel: influence of UV laser cross-linking on mechanical properties
The use of 3D printing of hydrogels as a cell support in bio-printing of cartilage, organs and tissue has attracted much research interest. For cartilage applications, hydrogels as soft materials must show some degree of...
Low cost additive manufacturing of microneedle masters
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Efficacy of using a 3D printed lumbosacral spine phantom in improving trainee proficiency and confidence in CT-guided spine procedures
All materials used in this study are publicly available for purchase.
Implementation of iterative metal artifact reduction in the pre-planning-procedure of three-dimensional physical modeling
Data is available by contacting the corresponding author.