The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is for comment only and includes technical considerations for such devices.
The draft guidance states that the FDA developed the guidance “to provide FDA’s initial thinking on technical considerations specific to devices using additive manufacturing” and to outline “recommendations for testing and characterization for devices that include at least one [Additive Manufacturing] fabrication step.” The document addresses two broad areas: 1) design and manufacturing considerations, and 2) device testing considerations including characterization, validation and verification.
However, the guidance is not comprehensive. According to the Regulatory Affairs Professionals Society (RAPS), the “FDA says the guidance is not intended to address 3D printed products containing biologics, cells or human tissues, and cautions that ‘point-of-care device manufacturing may raise additional technical considerations’ not covered in the draft guidance.”RAPS further indicates that the guidance resulted from a public workshop in 2014 and that “the major takeaways from the workshop include the importance of material control, the impact of the 3D printer and post-printing processes on final device performance and the need for a ‘robust process validation and acceptance protocol.’”
According to the FDA, the public has until early August to provide comments on the draft guidance.