FDA CDRH Center Science Council will Serve as an Internal Advisory and Decision-Making Body on Various Issues, Including Clinical Data Requirements and Trials
The Food and Drug Administration (FDA) issued a draft charter of the Center for Devices and Radiological Health (CDRH) Center Science Council (CSC) and fact sheet on March 31 that describes its responsibilities and organization.i The formation of the CSC was recommended in FDA’s August 2010 510(k) Working Group and Utilization of Science in Regulatory Decision Making Task Force Reports. Its purpose is to help CDRH better identify and incorporate evolving science and technology into regulatory decision-making and enhance both communication and utilization of scientific knowledge throughout the Center. The Chairperson of the CSC is the CDRH Deputy Center Director for Science, Dr. William Maisel.
Responsibilities of the CSC. The draft charter defines five core responsibilities:
- Identification and Incorporation of New Science into Regulatory Decision-Making. The CSC is charged with aiding in the establishment of standard procedures and business processes for determining, among other things, how CDRH reacts to new information, when external experts, stakeholders or other parties are needed to address new information, and when new information requires a change in regulatory policy.
- Oversight of Issues Related to Clinical Data and Clinical Trials. The CSC is responsible for developing standard procedures for assuring consistency in decisions related to clinical trials. In carrying out this responsibility, the CSC may, among other things, establish criteria for first-in-man clinical trials; put in place a device feasibility program that would facilitate iterative device design modifications based on pre-clinical and early human data; and determine when post-market clinical requirements, including clinical trial designs, should be changed based on new scientific information.
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