Draft guidance on additive manufactured devices issued
On May 10, 2016, the Food and Drug Administration (FDA) issued draft guidance, providing its initial thoughts on regulatory requirements for devices manufactured using additive manufacturing (AM), a category that includes three-dimensionally (3D) printed medical devices. AM enables companies to more easily design and create devices with complex or delicate internal structures. As AM can use data from a patient’s medical imaging to produce unique anatomically matched medical devices, the method may advance the field of personalised medicine. The draft guidance proposes a risk-based approach to the regulatory challenges posed by AM, including point-of-care manufacturing.