Article preview from "The Gray Sheet" - August 2, 2010
The Institute of Medicine committee charged with recommending reforms to FDA's 510(k) clearance program will move the remainder of its efforts behind closed doors.
By Jessica Bylander
Article preview from "The Gray Sheet" - August 2, 2010
The Institute of Medicine committee charged with recommending reforms to FDA's 510(k) clearance program will move the remainder of its efforts behind closed doors.
At the committee's final public meeting July 28, members said they will take a broad-based approach to contemplating potential changes to the program, including weighing whether the 510(k) law needs to be replaced outright.
In addition to recommending potential legislative changes, "it's
within our charge to comment on the process itself, and whether
it's the best method to protect patient health and promote
innovation," committee chair David Challoner, VP for health affairs
at the University of Florida, told reporters following the
Washington, D.C., meeting. To read this article in its entirety, purchase this article online or get it FREE when you subscribe to "The Gray Sheet". Plus:
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