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FDA to Host Public Workshop on Additive Manufacturing

UPDATE: Transcripts posted at FDA's site

On October 8-9, 2014 at its Silver Spring, Maryland campus, FDA will convene a forum for FDA, academia, device manufacturers and companies that supply additive manufacturing (AM) services. Specifically, FDA seeks input on technical assessments to consider for AM-created devices to provide a transparent evaluation process for future submissions.

From background information cited in the Federal Register notice,

"Process verification and validation are especially important when devices are produced individually or in very small batches. By discussing and addressing these technical challenges through an open forum, FDA would like to foster innovation with a transparent process and shared expectations for stakeholders. Participants in the workshop will include researchers, scientists, and engineers involved with the research and development of products using additive manufacturing as one or more steps of the manufacturing process. The intent is to address scientific and technical challenges posed by additive manufacturing process but not address specific printing technologies or medical device types. The latter will still be covered by their respective standards and guidance documents. Ideas generated during this workshop may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices."

Registration is free and required, including attendance by webcast; in-person seating and webcast connections are limited. In-person and webcast attendees must register online by 4:00 p.m. on September 30. Transcripts will be available ~45 days after the workshop at.

Topics for Discussion are found in the Federal Register notice, here.

Complete information, including the registration form, is located here.


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