Regulatory Interfaces Surrounding The Growing Field of Additive Manufacturing of Medical Devices and Biologic Products

The potential impacts of 3D printing in medicine appear to be remarkable, but regulatory pathways associated with the clinical translation of devices and products produced through 3D printing struggle to maintain pace with the rapidly evolving technologies.


Adamo et al. present in a recent article an overview of regulatory considerations in the development and translation of additive manufactured medical devices. The article highlights challenges associated with regulation of complex and often customized products that may comprise multiple materials, biologics, and cell populations. The authors underscore additional challenges associated with quality assurance, sourcing of materials, and product variability. Among several recommendations presented in the article, the authors make a case for increased funding and education to support continued development and informed regulation of medical products fabricated via additive manufacturing.

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Citation Information:

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

Adamo JE, Grayson WL, Hatcher H, Brown JS, Thomas A, Hollister S, Steele SJ. J Clin Transl Sci. 2018 Oct;2(5):301-304. doi: 10.1017/cts.2018.331. Epub 2018 Nov 29.

PMID: 30828471


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