Regulating 3D-printed medical products

Laura M Ricles; James C Coburn; Matthew Di Prima; Steven S Oh

doi:10.1126/scitranslmed.aan6521

Regulating 3D-printed medical products

Sci Transl Med. 2018 Oct 3;10(461):eaan6521. doi: 10.1126/scitranslmed.aan6521.

Authors

Laura M Ricles^{1

2}, James C Coburn³, Matthew Di Prima³, Steven S Oh⁴

Affiliations

¹ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, Silver Spring, MD 20993, USA.
² U.S. Food and Drug Administration, Office of the Commissioner, Commissioner's Fellowship Program, Silver Spring, MD 20993, USA.
³ U.S. Food and Drug Administration, Center for Device and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, MD 20993, USA.
⁴ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, Silver Spring, MD 20993, USA. steven.oh@fda.hhs.gov.

PMID: 30282697
DOI: 10.1126/scitranslmed.aan6521

Abstract

Additive manufacturing [also known as three-dimensional (3D) printing] is the layer-wise deposition of material to produce a 3D object. This rapidly emerging technology has the potential to produce new medical products with unprecedented structural and functional designs. Here, we describe the U.S. regulatory landscape of additive manufactured (3D-printed) medical devices and biologics and highlight key challenges and considerations.

Publication types

Review

MeSH terms

Animals
Biological Products / therapeutic use
Equipment and Supplies*
Humans
Printing, Three-Dimensional / legislation & jurisprudence*
Regenerative Medicine
Social Control, Formal*

Substances

Biological Products