PerspectiveRegulatory Science

Regulating 3D-printed medical products

See allHide authors and affiliations

Science Translational Medicine  03 Oct 2018:
Vol. 10, Issue 461, eaan6521
DOI: 10.1126/scitranslmed.aan6521

You are currently viewing the abstract.

View Full Text

Log in to view the full text

Log in through your institution

Log in through your institution

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.

View Full Text