Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Di Prima, Matthew, Coburn, James, Hwang, David, Kelly, Jennifer, Khairuzzaman, Akm, Ricles, Laura
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2016
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
_version_ 1783336646091997184
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
work_keys_str_mv AT diprimamatthew additivelymanufacturedmedicalproductsthefdaperspective
AT coburnjames additivelymanufacturedmedicalproductsthefdaperspective
AT hwangdavid additivelymanufacturedmedicalproductsthefdaperspective
AT kellyjennifer additivelymanufacturedmedicalproductsthefdaperspective
AT khairuzzamanakm additivelymanufacturedmedicalproductsthefdaperspective
AT ricleslaura additivelymanufacturedmedicalproductsthefdaperspective