Today FDA issued the final version of its guidance on additive manufacturing. “Technical Considerations for Additive Manufactured Medical Devices” makes recommendations regarding device design, manufacturing and testing considerations when developing devices that have at least one component that is additively manufactured or there is an additively fabricated step in the process.
“The unique aspects of the AM process, such as the layer-by-layer fabrication process, combined with the relative lack of experience and clinical history with respect to devices manufactured using AM techniques, pose challenges in determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and verification methods for these devices.” – FDA
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