Regulating 3D-printed medical products

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.

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