Regulating 3D-printed medical products

Science Translational Medicine
03 October 2018  Vol 10, Issue 461

Regulating 3D-printed medical products
By Laura M. Ricles, James C. Coburn, Matthew Di Prima, Steven S. Oh
Science Translational Medicine03 Oct 2018 Restricted Access
There are a number of key considerations in the U.S. regulatory landscape regarding approval of 3D-printed medical devices and biologics.
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.