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Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products

  • Joan E. Adamo (a1), Warren L. Grayson (a2), Heather Hatcher (a3), Jennifer Swanton Brown (a4), Andrika Thomas (a5), Scott Hollister (a6) and Scott J. Steele (a7)...

Abstract

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.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

Address for correspondence: J. E. Adamo, PhD, 265 Crittenden Blvd CU 420708 Rochester, NY 14642, USA. Email: joan_adamo@urmc.rochester.edu

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Keywords

Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products

  • Joan E. Adamo (a1), Warren L. Grayson (a2), Heather Hatcher (a3), Jennifer Swanton Brown (a4), Andrika Thomas (a5), Scott Hollister (a6) and Scott J. Steele (a7)...

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