Experts Say Medical Device Review System Flawed

The Miami Herald, July 29, 2011. NRC President Diana Zuckerman expresses concern over the vast majority of medical devices being cleared through the 510(k) process—a process which has been described as “flawed” by Institute of Medicine panelists in a new report.

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Warning About Pelvic Mesh

WCAX, July 15, 2011. NRC President Diana Zuckerman tells WCAX that pelvic mesh devices have “been used despite no clinical trials, no testing on humans to see if they’re actually safe and effective.

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Report Could Sway FDA Device Review Process

Reuters, July 26, 2011. President of the National Research Center for Women & Families Diana Zuckerman is critical of the FDA for not moving sooner to make changes to the device approval process. She says “the whole process is illogical” and “in some kind of ideal world the FDA would have come out with these proposals and implemented them.”

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