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:

• Audio Playback: FDA Discussion on the Draft 510(k) and Use of Science in Regulatory Decision Making Reports

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Related Documents

• CDRH Preliminary Internal Evaluations -- Foreword: A Message from the Center Director
• CDRH Preliminary Internal Evaluations -- Volume I: 510(k) Working Group Preliminary Report and Recommendations
• CDRH Preliminary Internal Evaluations -- Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations

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Related Links

• Federal Register: CDRH 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations
• CDRH Preliminary Internal Evaluations -- Basic Questions and Answers on Preliminary Reports