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  1. About the Center for Devices and Radiological Health

CDRH Preliminary Internal Evaluations

CDRH Preliminary Internal Evaluations

The links below provide two comprehensive assessments on the 510(k) premarket review process and the use of science in CDRH’s regulatory decision making.

FDA has published a notice in the Federal Register requesting public comment on these reports. Please see Docket No. FDA-2010-N-0348, "Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations; Availability for Comment."

On Tuesday, August 31, 2010, CDRH hosted a live webinar to discuss the details of both reports and respond to any questions and concerns raised by the medical device community. An audio playback of this webinar is available:


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