Today, the FDA issued the final version of the guidance, “Technical Considerations for Additive Manufactured Medical Devices." Additive manufacturing (AM), the broad category of manufacturing encompassing 3-dimensional (3D) printing, is an emerging technology. This guidance is not intended to introduce new policy, but rather outlines the Agency’s current thinking about the technical aspects associated with AM processes, and provides manufacturers with recommendations for device design, manufacturing, and testing considerations for use when developing devices that include at least one additively manufactured component or additively fabricated step.
In medical device applications, AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient's own medical imaging data. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered open lattice structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches. However, 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. For devices manufactured using AM, the recommendations in this guidance supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.
On January 10, 2018, the FDA will hold a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.
Date: January 10, 2018
Time: 1:00 – 2:30 PM, Eastern Time. To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar
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If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or firstname.lastname@example.org.
Food and Drug Administration