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.
CDRH officials, including Director Jeff Shuren, provided important incremental updates on upcoming guidance documents, the governance of FDA’s national post-market surveillance program and initial outcomes from the agency’s 510(k) refuse-to-accept policy at the AdvaMed 2013 MedTech Conference Sept. 23-25 in Washington, D.C. The highlights are below.
FDA will issue the final guidance on early feasibility studies in the “very, very, very, very, very, very near future,”...
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
