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FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Date:8/4/2010

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CDRH established two staff committees on these issues in late 2009 as part of its 2010 strategic plan. The committees collected and reviewed input from public meetings, open dockets, data analyses, and input from CDRH staff over the course of several months to prepare the complementary evaluations.

In recent years, concerns have been raised both inside and outside of the FDA about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while fostering innovation. Concerns about the program have centered on whether it allows devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency, and transparency is hindering device development.

CDRH uses science to guide its regulation of medical devices across the total product lifecycle. At any stage of that lifecycle, new, unfamiliar or unexpected scientific information may arise that warrants a change in the FDA's thinking, expectations, and actions. CDRH is seeking to strike the right balance between the ability to adapt its approach as new science emerges and to provide predictable regulatory pathways.

"Taken together, these preliminary reports show a smarter FDA – an agency that recognizes both sides of our mission to protect and promote public health," said CDRH Director Jeffrey Shuren, M.D. "The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.


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SOURCE U.S. Food and Drug Administration
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