FDA Issues Draft Guidance For 3D-Printed Medical Devices

The U.S. Food and Drug Administration (FDA) has released draft guidance containing technical considerations in additive manufacturing (AM), the broad category of manufacturing encompassing 3-dimensional (3D) printing. The "leap-frog" guidance adds some clarity regarding FDA's initial approach to anticipated regulation of a growing number of 3D-printed medical devices.
Source: Medical Design Online News - Category: Medical Equipment Source Type: news