On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices. The document "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff" is meant to outline the agency's current thinking about devices made via these processes and will be supplemented by a webinar in January. More information on the webinar is available here.
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The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing.