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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:
Related Documents
- CDRH Preliminary Internal Evaluations -- Foreword: A Message from the Center Director (PDF - 243KB)
CDRH Preliminary Internal Evaluations -- Volume I: 510(k) Working Group Preliminary Report and Recommendations (PDF - 1.8MB)CDRH Preliminary Internal Evaluations -- Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations (PDF - 672KB)
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 - Press Release: FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
CDRH Preliminary Internal Evaluations -- Basic Questions and Answers on Preliminary Reports
