On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an … Continue Reading
The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where … Continue Reading
On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,” which reconfirms its position on the importance of 3D printed medical devices. The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., … Continue Reading
The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading
3D printing is providing physicians with a steady flow of new options for medical treatment. Reports are constantly emerging about novel, life-saving procedures made possible through 3D printing. As one might imagine, however, 3D printing a medical device for use in humans carries particular challenges not present with 3D printing in other contexts.… Continue Reading