CDRH To Abandon Bad Precedents On Path To Predictable 510(k)s
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center wants to make the 510(k) process more predictable, but one of the first steps to accomplishing this is to break from what CDRH acknowledges are some questionable past decisions, according to a top Office of Device Evaluation official
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CMS In Brief
Coverage with evidence for stem cell transplants?: CMS proposes May 6 to allow coverage with evidence development for allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome, a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells (1"The Gray Sheet" Nov. 30, 2009). The proposed coverage memo outlines criteria for prospective controlled clinical studies, including the need to address specified treatment outcomes and to adhere to strict standards of scientific integrity. CMS is taking comments through June 5 and plans a final rule by Aug. 4
CMS In Brief
Coverage with evidence for stem cell transplants?: CMS proposes May 6 to allow coverage with evidence development for allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome, a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells (1"The Gray Sheet" Nov. 30, 2009). The proposed coverage memo outlines criteria for prospective controlled clinical studies, including the need to address specified treatment outcomes and to adhere to strict standards of scientific integrity. CMS is taking comments through June 5 and plans a final rule by Aug. 4
Dealmaking in 2009: A Look Back and A Glance Ahead
This article was excerpted from "Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk," IN VIVO, January 2010.