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On December 5, 2017, 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. As a result, this leap-frog 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.

On January 10, 2018, the FDA held a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions.

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NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

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 at [email protected].