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CDRH Officials Talk New Guidance, Post-Market Surveillance And 510(k)s At AdvaMed

This article was originally published in The Gray Sheet

Executive Summary

CDRH Director Jeffrey Shuren told participants at the AdvaMed annual meeting to expect early feasibility studies final guidance very soon and a guidance on 3D printing within two years. The center also announced updates on its national post-market surveillance plan and 510(k) refuse-to-accept policy programs, among other matters.

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