CDRH Publishes Plan of Action to Improve the 510(k) Process

In August 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released for public comment the preliminary reports from the 510(k) Working Group and Task Force on the Utilization of Science in Regulatory Decision Making. These committees were charged with evaluating the 510(k) program and exploring actions CDRH could take to enhance the effectiveness and predictability of the 510(k) clearance process and the incorporation of new scientific information by CDRH into its decision making. Following the release of these reports, the FDA received a range of perspectives during the public comment period.

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