Walter Reed Gets Premarket Clearance to Make 3D Printed Point-of-Care Medical Devices

The Walter Reed National Military Medical Center’s 3-D Medical Application Center (3-D MAC) has received premarket clearance to make 3D printed medical devices. This is the first time that a point-of-care institution has gotten clearance to make patient-specific devices in-house. The FDA will now let the 3-D MAC make its Titanium Cranial Plate (TCP) System in-house. 3D Systems helped the VA get to this point, assisting with the regulatory process, process control, and design optimization, and helping them set up a quality management system (QMS). The VA also got support from Defense Health Agency’s (DHA) Office of Regulated Activities (ORA).

3D Systems CEO Jeff Graves said,

“We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalized medical d