Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products
Rapidly advancing technology often pulls the regulatory field along as it evolves to incorporate new concepts, better tools, and more finely honed equipment. When the area impacted by the technological advancement is regulated by the Food and Drug Administration (FDA), a gap develops between the tec...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2018-10-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S205986611800331X/type/journal_article |
| _version_ | 1811156834727231488 |
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| author | Joan E. Adamo Warren L. Grayson Heather Hatcher Jennifer Swanton Brown Andrika Thomas Scott Hollister Scott J. Steele |
| author_facet | Joan E. Adamo Warren L. Grayson Heather Hatcher Jennifer Swanton Brown Andrika Thomas Scott Hollister Scott J. Steele |
| author_sort | Joan E. Adamo |
| collection | DOAJ |
| description | Rapidly advancing technology often pulls the regulatory field along as it evolves to incorporate new concepts, better tools, and more finely honed equipment. When the area impacted by the technological advancement is regulated by the Food and Drug Administration (FDA), a gap develops between the technology and the guidelines that govern its application. Subsequently, there are challenges in determining appropriate regulatory pathways for evolving products at the initial research and developmental stages. Myriad factors necessitate several rounds of iterative review and the involvement of multiple divisions within the FDA. To better understand the regulatory science issues roiling around the area of additive manufacturing of medical products, a group of experts, led by a Clinical and Translational Science Award working group, convened the Regulatory Science to Advance Precision Medicine at the Fall Forum to discuss some of the current regulatory science roadblocks. |
| first_indexed | 2024-04-10T04:57:44Z |
| format | Article |
| id | doaj.art-1ed40a30c06a4160ab6d55fe222a3c3f |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:57:44Z |
| publishDate | 2018-10-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-1ed40a30c06a4160ab6d55fe222a3c3f2023-03-09T12:29:41ZengCambridge University PressJournal of Clinical and Translational Science2059-86612018-10-01230130410.1017/cts.2018.331Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic productsJoan E. Adamo0Warren L. Grayson1Heather Hatcher2Jennifer Swanton Brown3https://orcid.org/0000-0003-3811-9173Andrika Thomas4Scott Hollister5Scott J. Steele6Clinical & Translational Science Institute, Biomedical Engineering Department, University of Rochester Medical Center, Rochester, NY, USATranslational Tissue Engineering Center, Johns Hopkins University School of Medicine, Baltimore, MD, USAWomble Bond Dickinson (US) LLP, Winston-Salem, NC, USASpectrum, Stanford Center for Clinical & Translational Research & Education, Stanford, CA, USACore Laboratory of the Clinical & Translational Science Center, Weill Cornell Medicine, New York, NY, USACenter for 3D Medical Fabrication and Department of Biomedical Engineering, Georgia Institute of Technology/Emory University, Atlanta, GA, USAClinical & Translational Science Institute, Department of Public Health Science, University of Rochester Medical Center, Rochester, New York, NY, USARapidly advancing technology often pulls the regulatory field along as it evolves to incorporate new concepts, better tools, and more finely honed equipment. When the area impacted by the technological advancement is regulated by the Food and Drug Administration (FDA), a gap develops between the technology and the guidelines that govern its application. Subsequently, there are challenges in determining appropriate regulatory pathways for evolving products at the initial research and developmental stages. Myriad factors necessitate several rounds of iterative review and the involvement of multiple divisions within the FDA. To better understand the regulatory science issues roiling around the area of additive manufacturing of medical products, a group of experts, led by a Clinical and Translational Science Award working group, convened the Regulatory Science to Advance Precision Medicine at the Fall Forum to discuss some of the current regulatory science roadblocks.https://www.cambridge.org/core/product/identifier/S205986611800331X/type/journal_articleRegulatory scienceadditive manufacturing3D printingprecision medicineFDA |
| spellingShingle | Joan E. Adamo Warren L. Grayson Heather Hatcher Jennifer Swanton Brown Andrika Thomas Scott Hollister Scott J. Steele Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products Journal of Clinical and Translational Science Regulatory science additive manufacturing 3D printing precision medicine FDA |
| title | Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products |
| title_full | Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products |
| title_fullStr | Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products |
| title_full_unstemmed | Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products |
| title_short | Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products |
| title_sort | regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products |
| topic | Regulatory science additive manufacturing 3D printing precision medicine FDA |
| url | https://www.cambridge.org/core/product/identifier/S205986611800331X/type/journal_article |
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