The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.
Additively manufactured medical products – the FDA perspective
Open accessAbstract
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.
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Citations
Cites
3D bioprinting of tissues and organs
Murphy, S. V., & Atala, A. (2014) · Nature Biotechnology · doi:10.1038/nbt.2958 · Cited by 7,034
A new chapter in pharmaceutical manufacturing: 3D-printed drug products
Norman, J., Madurawe, R. D., Moore, C. M. V., Khan, M. A., & Khairuzzaman, A. (2017) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2016.03.001 · Cited by 810
Self-citationApplication of inkjet printing to tissue engineering
Boland, T., Xu, T., Damon, B., & Cui, X. (2006) · Biotechnology Journal · doi:10.1002/biot.200600081 · Cited by 783
3D biofabrication strategies for tissue engineering and regenerative medicine
Bajaj, P., Schweller, R. M., Khademhosseini, A., West, J. L., & Bashir, R. (2014) · Annual Review of Biomedical Engineering · doi:10.1146/annurev-bioeng-071813-105155 · Cited by 632
Medical 3D Printing for the Radiologist
Mitsouras, D., Liacouras, P., Imanzadeh, A., Giannopoulos, A. A., Cai, T., Kumamaru, K. K., George, E., Wake, N., Caterson, E. J., Pomahac, B., et al. (2015) · RadioGraphics · doi:10.1148/rg.2015140320 · Cited by 619
Bioresorbable Airway Splint Created with a Three-Dimensional Printer
Zopf, D. A., Hollister, S. J., Nelson, M. E., Ohye, R. G., & Green, G. E. (2013) · New England Journal of Medicine · doi:10.1056/nejmc1206319 · Cited by 589
Morrison, R. J., Hollister, S. J., Niedner, M. F., Mahani, M. G., Park, A. H., Mehta, D. K., Ohye, R. G., & Green, G. E. (2015) · Science Translational Medicine · doi:10.1126/scitranslmed.3010825 · Cited by 498
Three-Dimensional Printing and Medical Imaging: A Review of the Methods and Applications
Marro, A., Bandukwala, T., & Mak, W. (2016) · Current Problems in Diagnostic Radiology · doi:10.1067/j.cpradiol.2015.07.009 · Cited by 379
Toward engineering functional organ modules by additive manufacturing
Marga, F., Jakab, K., Khatiwala, C., Shepherd, B., Dorfman, S., Hubbard, B., Colbert, S., & Gabor, F. (2012) · Biofabrication · doi:10.1088/1758-5082/4/2/022001 · Cited by 348
Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices
Morrison, R. J., Kashlan, K. N., Flanangan, C. L., Wright, J. K., Green, G. E., Hollister, S. J., & Weatherwax, K. J. (2015) · Clinical and Translational Science · doi:10.1111/cts.12315 · Cited by 290
Cited by
Additive manufacturing (3D printing): A review of materials, methods, applications and challenges
Ngo, T. D., Kashani, A., Imbalzano, G., Nguyen, K. T. Q., & Hui, D. (2018) · Composites Part B: Engineering · doi:10.1016/j.compositesb.2018.02.012 · Cited by 8,431
Seifi, M., Gorelik, M., Waller, J., Hrabe, N., Shamsaei, N., Daniewicz, S., & Lewandowski, J. J. (2017) · JOM · doi:10.1007/s11837-017-2265-2 · Cited by 422
Metadata
- Authors
- Di Prima, M., Coburn, J., Hwang, D., Kelly, J., Khairuzzaman, A., & Ricles, L.
- Venue
- 3D Printing in Medicine
- Published
- 2016-12
- Volume
- 2
- Issue
- 1
- ISSN
- 2365-6271 (ISSN-L)
- OpenAlex
- W2406557342
- Cited by
- 328
- References
- 17
- FWCI
- 24.78
- Type
- journal article
- Language
- en
- Open access
- gold
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- Di Prima, M., Coburn, J., Hwang, D., Kelly, J., Khairuzzaman, A., & Ricles, L. (2016). Additively manufactured medical products – the FDA perspective. 3D Printing in Medicine. https://doi.org/10.1186/s41205-016-0005-9
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
