April 3, 2013
Center for Devices and Radiological Health
U.S. Food and Drug Administration
The purpose of this charter is to describe the duties and responsibilities of the CDRH Center Science Council (CSC) including the organization of its membership and its operating procedures.
CDRH’s 2011 Action Plan for implementation of the 510(k) Working Group and Utilization of Science in Regulatory Decision Making Task Force Reports’ recommendations included the formation of a Center Science Council to help the Center meet its two public health goals of facilitating innovation and assuring that medical devices are safe and effective. The CSC will provide oversight of the Center’s science programmatic functions and help share knowledge throughout the Center, consistent with CDRH’s other ongoing efforts to improve internal communication, consistency, transparency, and quality in scientific decision making, and predictability of regulatory pathways and requirements.
The CSC is an advisory and decision-making body comprised of senior CDRH staff with the following responsibilities:
IDENTIFICATION AND INCORPORATION OF NEW SCIENCE and TECHNOLOGY INTO REGULATORY DECISION-MAKING The CSC will oversee the development, implementation, and administration of standard operating procedures and business processes for:
1.1 Identification of new science and technology relevant to the Center’s mission;
1.2 Determining the appropriate Center response to new science and technology, including the establishment of new policy, engagement of
external experts or stakeholders, formation of an internal working group or task force, or other action as deemed appropriate by the CSC;
1.3 Incorporation of new and evolving science and technology into regulatory decision-making;
1.4 Monitoring appropriateness, consistency, transparency, effectiveness, and efficiency of CDRH’s response to new science and technology;
1.5 Identification of CDRH’s scientific priorities.
ISSUES RELATED TO CLINICAL DATA AND CLINICAL STUDIES
The CSC will provide oversight of clinical data requirements and clinical study policy and decision-making by establishing standard operating procedures or policies that promote appropriate, consistent, and transparent decision-making. For example, the CSC may:
2.1 Establish criteria for permitting or denying approval of first-in-human studies;
2.2 Develop a Device Feasibility Study Program that safely facilitates iterative device design modifications based on outcomes of pre-clinical testing and
early human studies;
2.3 Establish Center policies and criteria for timely supervisory review of pre-IDE and IDE decisions to support industry;
2.4 Promote the development of higher quality IDE submissions;
2.5 Foster the incorporation of under-represented populations into device studies;
2.6 Serve as a resource for staff seeking advice on clinical study design
2.7 Determine whether or not premarket or postmarket clinical data requirements, including clinical study designs, should be changed based on new scientific information.
2.8 Develop policies to promote appropriate and consistent application of relevant postmarket clinical data to premarket product evaluation.
MANAGEMENT AND OVERSIGHT OF THE INNOVATION PATHWAY
The CSC will help manage the Innovation Pathway by supervising its implementation and providing continued oversight, including:
3.1 Establishment of criteria and processes for consideration of products applying for the Innovation Pathway;
3.2 Assessment and selection of product applications for the Innovation Pathway based on criteria established by the CSC and resource availability.
3.3 Provide input on, and support for, professional development opportunities to promote high quality product review.
3.4 Provide recommendations based on Innovation Pathway experience for improvements to CDRH premarket and postmarket review processes.
QUALITY MANAGEMENT OF CENTER’S SCIENTIFIC PROGRAMMATIC FUNCTIONS
4.1 Develop metrics to monitor the performance of CDRH’s scientific programmatic functions;
4.2 Periodically audit the Center’s scientific programs and decisions to assess appropriateness, effectiveness, efficiency, and consistency;
4.3 Provide recommendations for improvement in the performance of the Center's scientific programs. This will include both scientific and regulatory quality aspects.
OVERSIGHT AND PRIORITIZATION OF CROSS-CENTER ISSUES OF PUBLIC HEALTH IMPORTANCE
The CSC will prioritize, manage, and help address important public health issues that generally involve or impact multiple Center disciplines and offices. The CSC will develop mechanisms for identifying issues for its consideration, and prioritize those issues based on public health impact, available resources, and expediency. For issues selected for further evaluation, CSC Staff will work with appropriate CDRH and FDA staff, and external stakeholders, to:
5.1 Identify and facilitate information collection and analysis;
5.2 Conduct a risk assessment, where appropriate;
5.3 Supervise action plan development and implementation;
5.4 Monitor and track management of the issue.
The CSC’s recommended public health response to an issue may include short term efforts (e.g., communication with the public, adverse event analysis, recommendations for a public Advisory Committee meeting, outreach to external stakeholders) and/or longer term efforts (e.g., guidance documents, standards development activities, regulation development, research activities).
4.1.1 Core Members
Core members are expected to participate in all CSC meetings. CSC core membership includes:
- Deputy Center Director for Science, (CSC Chairperson)
- Associate Director for Science (CSC Vice-Chairperson)
- Center Director
- Deputy Center Director for Policy*
- Associate Director for Technology and Innovation
- Assistant Director for Science
- Chief Pediatric Medical Officer
- Quality Management Subcommittee Chair
- Director, Office of Device Evaluation (ODE)*
- Director, Office of In Vitro Device Evaluation and Safety (OIR)*
- Director, Office of Compliance (OC)*
- Director, Office of Surveillance and Biometrics (OSB)*
- Director, Office of Science and Engineering Laboratories (OSEL)*
- One Additional Representative each from ODE, OIR, OC, OSB, OSEL**
- Four Reviewer Representative**
o One Medical Officer
o Three Reviewer Representatives (ODE, OIR, OSEL)
Four Senior Medical Officer Representative*(OSB, ODE, OIR, OC)
oTwo Clinical Trial Experts***(statistics and medical)
* Alternates will also be identified. Alternates are expected to attend when the Core member is unable.
** Office, Medical Officer, Reviewer, and Clinical Trial Representatives and alternates serve 2 year terms and may be nominated for reappointment.
*** One of the Clinical Experts is the Chair of the Clinical Data and Clinical Studies
Membership in the Subcommittee consists of a Chair, a Vice Chair, standing members, and temporary or ad hoc members. Subcommittee members serve 2 year terms and will report to the Core CSC quarterly – or more often as needed.
Subcommittees may be added or terminated by the CSC Chairperson or by vote of the CSC.
Three initial CSC subcommittees will be established and have their own charters.
188.8.131.52 Innovation Pathway Subcommittee
Chairperson – Associate Director for Technology and Innovation*
Charge – Provide management, oversight, and selection of products for the Center’s Innovation Pathway
184.108.40.206 Quality Management Subcommittee
Chairperson – Associate Director of Quality*
Charge – Monitor the performance of the Center’s science programmatic functions as directed by the CSC
220.127.116.11 Clinical Data and Clinical Studies Subcommittee
Chairperson – CSC Clinical Study Expert
Charge – Address issues related to clinical data and clinical studies as directed by the CSC
18.104.22.168 Regulatory Science Subcommittee
Chairperson – Associate Director for Science
Charge – Proactively enhance medical device innovation, development, safety, quality, and efficacy
4.1.3 Ad Hoc Members
The CSC or CSC Subcommittees may invite additional CDRH staff to participate in CSC or CSC Subcommittee meetings as temporary ad hoc members when necessary to ensure that the needed expertise is represented. Ad hoc members must be nominated by an Office Director or Deputy Director for Science and are selected by the CSC or CSC Subcommittee Chairperson.
*If the position is vacant, the CSC Chair will appoint a sub-committee chairperson
4.2 CSC Staff
CSC Staff will be comprised of Senior Science Health Advisors, Project Managers, an Executive Secretary, and Support Staff who will report to the Assistant Director for Science
CSC meetings will be held at least monthly or more frequently as needed;
CSC Subcommittees will meet according to a schedule determined by the Subcommittee Chairperson.
22.214.171.124 Meeting management
Meeting schedules will be determined by the CSC Chair;
A quorum is defined as two-thirds of the core members. A quorum must be present to hold a meeting.
Agendas will be developed and circulated at least 5 working days before a meeting to the attendees;
Modifications to the Agenda will be considered at the discretion of the CSC Chair;
Documents requiring review prior to the meeting will be circulated not Less than 72 hours prior to the meeting.
Meeting minutes will be kept for all full committee meetings;
The contents of the minutes will be circulated among the committee members for completeness and accuracy;
Meeting minutes will be posted for Center-wide access.
126.96.36.199 CSC Decision-Making
CSC decisions and recommendations will be made by a two-thirds majority vote of a CSC quorum. If it is not feasible to reach a decision or recommendation through a vote within the allotted time frame, the Chair may elect to make the decision;
Product selection for the Innovation Pathway will be made under the direction of the Associate Director for Technology and Innovation;
CSC decisions and recommendations are subject to review by the Center Director at his/her discretion. If the Center Director overrules a CSC decision or recommendation, he/she must draft a memorandum explaining the basis for his/her decision and discuss his/her decision and rationale with the CSC if it is feasible to convene a CSC quorum within an appropriate time frame;