Semantic Scholar Open Access 2016 275 sitasi

Additively manufactured medical products – the FDA perspective

M. D. Di Prima J. Coburn David Hwang J. Kelly A. Khairuzzaman +1 lainnya

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Abstrak

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.

Topik & Kata Kunci

Medicine Engineering

Penulis (6)

M. D. Di Prima

J. Coburn

David Hwang

J. Kelly

A. Khairuzzaman

L. Ricles

Format Sitasi

APA MLA BibTeX

Prima, M.D.D., Coburn, J., Hwang, D., Kelly, J., Khairuzzaman, A., Ricles, L. (2016). Additively manufactured medical products – the FDA perspective. https://doi.org/10.1186/s41205-016-0005-9

Akses Cepat

Lihat di Sumber doi.org/10.1186/s41205-016-0005-9

Informasi Jurnal

Tahun Terbit: 2016
Bahasa: en
Total Sitasi: 275×
Sumber Database: Semantic Scholar
DOI: 10.1186/s41205-016-0005-9
Akses: Open Access ✓