Life Sciences Legal Update

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an overview of the Guidance and answer questions. 

The presentation was a joint effort from several offices within the FDA’s organization and presenters included FDA employees, Matthew Di Prima, James Coburn (both of the Office of Science and Engineering Laboratories), Eric Horowitz (Office of Science and Engineering Laboratories), David Hwang, Joel Anderson (both of the Office of Device Evaluation) and Nooshin Kiarashi (Office of In Vitro Diagnostics and Radiological Health).

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