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Additively manufactured medical products – the FDA perspective
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 (FD...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027614/ https://www.ncbi.nlm.nih.gov/pubmed/29974058 http://dx.doi.org/10.1186/s41205-016-0005-9 |
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author | Di Prima, Matthew Coburn, James Hwang, David Kelly, Jennifer Khairuzzaman, Akm Ricles, Laura |
author_facet | Di Prima, Matthew Coburn, James Hwang, David Kelly, Jennifer Khairuzzaman, Akm Ricles, Laura |
author_sort | Di Prima, Matthew |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6027614 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-60276142018-07-02 Additively manufactured medical products – the FDA perspective Di Prima, Matthew Coburn, James Hwang, David Kelly, Jennifer Khairuzzaman, Akm Ricles, Laura 3D Print Med Review 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. Springer International Publishing 2016-12-01 /pmc/articles/PMC6027614/ /pubmed/29974058 http://dx.doi.org/10.1186/s41205-016-0005-9 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Review Di Prima, Matthew Coburn, James Hwang, David Kelly, Jennifer Khairuzzaman, Akm Ricles, Laura Additively manufactured medical products – the FDA perspective |
title | Additively manufactured medical products – the FDA perspective |
title_full | Additively manufactured medical products – the FDA perspective |
title_fullStr | Additively manufactured medical products – the FDA perspective |
title_full_unstemmed | Additively manufactured medical products – the FDA perspective |
title_short | Additively manufactured medical products – the FDA perspective |
title_sort | additively manufactured medical products – the fda perspective |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027614/ https://www.ncbi.nlm.nih.gov/pubmed/29974058 http://dx.doi.org/10.1186/s41205-016-0005-9 |
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