May 11, 2016

FDA Offers Draft Recommendations for Devices Produced Through Additive Manufacturing

‘Leapfrog’ Guidance Marks Agency’s Next Step Toward Regulating 3D Printing, Related Technologies

Through draft guidance issued by two FDA centers May 10, the FDA continues to wrestle with the novel regulatory and technical issues posed by medical devices developed through additive manufacturing (AM) methodologies, including thr...

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