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Draft guidance released by FDA concerning additive manufacturing technologies for 3D printed medical devices

The U.S. Food and Drug Administration (FDA) has issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices. The guidance resulted from a public workshop in 2014 and 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.

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and cautions that point of care device manufacturing may raise additional technical considerations, not covered in the draft guidance.

According to FDA the guidance has been developed 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 two broad areas taken into consideration by the guidance document are:

• design and manufacturing considerations
• device testing considerations including characterization, validation and verification.



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