Posted by Michael Wonder on 04 Dec 2017
Statement by FDA Commissioner on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
4 December 2017 - The agency is the first in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.
Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D printed medical products through access to personalised devices and innovative drugs that have led to significant health improvements.
But the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.
