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510(k) Face-Off: CDRH's Foreman Debates Reform Plans With Industry Reps

Executive Summary

The 510(k) program and plans by FDA to reform it have caught the attention and anxieties of the device industry. And Christy Foreman's frequent flyer miles have swelled as a result. The acting director of the Office of Device Evaluation within the agency's Center for Devices and Radiological Health (CDRH) has traveled from coast to coast answering questions and attempting to allay concerns about FDA's plans for the 510(k) program, which is used by companies to bring more than 90% of new devices to the US market. In late October, Foreman participated in a panel at Elsevier Business Intelligence's IN3 Summit in San Francisco. There, she joined two other prominent individuals in the industry for a discussion of the 510(k) program and possible impending changes to it.
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