On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”.
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On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more