US FDA Draft Guidance Tackles Medical Device 3-D Printing
This article was originally published in Clinica
Executive Summary
The US FDA has published a draft 'leapfrog' guidance on 3-D printing of medical devices that draws from a 2014 agency workshop on the topic. The guidance outlines key issues manufacturers should think about when designing products made with 3-D printers, including the materials used to make those devices and considerations when planning devices specific to individual patients.