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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: