The U.S. FDA’s Center for Devices and Radiological Health has outlined the benefits and challenges of using 3D printing in hospitals and physician offices, as well as three instances where 3D printing can be a boon to point-of-care manufacturing. 

There are three scenarios for production: a healthcare facility using a 3D printing medical device production system, in which the manufacturer assumes responsibilities for FDA regulatory requirements; a manufacturer on or near the healthcare facility site, with the provider organization not engaging in any 3D printing activities; and a healthcare facility assuming all responsibilities in compliance with FDA regulatory requirements applicable to device manufacturers.

“3D printing at hospitals and other patient-care settings enables healthcare professionals to quickly create patient-matched devices and anatomical models for surgical planning, as well as many other uses that can help healthcare facilities rapidly respond to patient needs,” CDRH’s William Maisel, director of the Office of Product Evaluation and Quality, and Ed Margerrison, director of the Office of Science and Engineering Laboratories, said in a statement. 

Read the full article on MedTechDive.