March 20, 2015
Center for Devices and Radiological Health
U.S. Food and Drug Administration
This charter describes the organization and responsibilities of the CDRH Center Science Council (CSC).
In 2011, CDRH created an Action Plan to implement recommendations made in the 510(k) Working Group and Utilization of Science in Regulatory Decision Making Task Force Reports. This plan 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 is an advisory and decision-making body comprised of Center leadership and other CDRH scientific and regulatory staff. Through regularly scheduled formal meetings, the CSC provides a forum for discussions and decision-making regarding the Center’s scientific programs and regulatory, scientific, and engineering issues. The CSC also facilitates the sharing of knowledge throughout the Center. In addition, the CSC supports CDRH’s ongoing efforts to improve internal communication, consistency, transparency, and quality in scientific and regulatory decision-making and operations.
3.1 IDENTIFICATION AND INCORPORATION OF NEW SCIENCE and TECHNOLOGY INTO REGULATORY DECISION-MAKING
The CSC and its staff oversee the development, implementation, and administration of standard operating procedures (SOPs) and business processes for:
3.1.1 Identifying new science and technology relevant to the Center’s mission.
3.1.2 Determining the appropriate Center response to new science and technology, including the establishment of new policy, engagement of external experts or stakeholders, formation of internal working groups or task forces, and/or other appropriate actions.
3.1.3 Incorporating new and evolving science and technology into regulatory decision-making.
3.1.4 Monitoring the appropriateness, consistency, transparency, effectiveness, and efficiency of CDRH’s response to new science and technology.
3.1.5 Identifying CDRH’s scientific priorities.
3.2 OVERSEE AND PRIORITIZE CROSS-CENTER ISSUES OF PUBLIC HEALTH IMPORTANCE
3.2.1 Develop and implement policy and program oversight of Center Working Groups (CWGs). Develop processes to facilitate CWGs obtaining CSC advice and fulfilling their responsibility to report the status of their work.
3.2.2 Provide advice regarding use of the Immediately in Effect Guidance pathway as outlined in the CDRH Standard Operating Procedure (SOP): Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues.
3.2.3 Provide a forum for broad Center input on scientific and regulatory issues.
3.3 UPHOLD QUALITY MANAGEMENT PRINCIPLES
The CSC is expected to embody the quality management (QM) principles outlined in the CDRH Quality Management Framework. Therefore, the CSC will:
3.3.1 Use the QM principles outlined in the framework to govern its own work.
3.3.2 Use the QM principles outlined in the framework to govern the work of the CSC staff.
3.3.3 Ensure the QM principles are being used to address issues brought to the CSC for discussion or vote.
4.1 CENTER SCIENCE COUNCIL
The CSC is comprised of the Center Director, voting members, non-voting members, alternate members, and ad hoc members. Members cannot fill more than one membership position, and cannot serve as an alternate for another member. The two-year terms referenced below begin on May 1, 2015 and every two years thereafter.
The following members must each nominate an alternate member from their office at the beginning of each two-year term to participate in CSC meetings in their absence. Alternate members must be approved by the CSC Chair.
- Deputy Center Director for Science, (CSC Chairperson)
- Associate Director for Science (CSC Vice-Chairperson)
- Center Director
- Deputy Center Director for Policy
- Assistant Director for Science
- Associate Director for Technology and Innovation
- Associate Director of Quality
- Director, Office of Compliance (OC)
- Director, Office of Device Evaluation (ODE)
- Director, Office of In Vitro Diagnostics and Radiological Health (OIR)
- Director, Office of Surveillance and Biometrics (OSB)
- Director, Office of Science and Engineering Laboratories (OSEL)
The following members are nominated for two-year terms by their Office Directors and must be approved by the CSC Chair. If a member leaves the CSC prior to the end of the two-year term, the Office Director will nominate another representative from that Office to serve the remainder of the term. This nomination must also be approved by the CSC Chair.
- One additional representative from OC
- One additional representative from ODE
- One additional representative from OIR
- One additional representative from OSB
- One additional representative from OSEL
The CSC may invite additional staff to participate in a CSC meeting as temporary ad hoc members to ensure that the needed expertise is represented during the meeting. Ad hoc members are nominated by the CSC meeting management team, presentation team, an Office Director, the CSC Chair, or the CSC Vice-Chair and are approved by the Assistant Director for Science before being invited to participate.
4.2 CSC STAFF
The CSC staff includes Senior Science Health Advisors, Regulatory Health Project Managers, and support staff who report to the Assistant Director for Science.
4.3 CSC SUBCOMMITTEES
The CSC Chair may create subcommittees to address CSC responsibilities. These subcommittees may either be standing (created to address an ongoing CSC requirement) or temporary (created to address a short-term need). CSC Subcommittees consist of a Chair, a Vice-Chair, and standing members. Standing subcommittee members serve two year terms.
Subcommittees may invite additional staff to participate as temporary ad hoc members to ensure that the needed expertise is represented on the Subcommittees. Ad hoc members are nominated by the Subcommittee, an Office Director, the CSC Chair, or the CSC Vice-Chair, and are approved by the Assistant Director for Science before being invited to participate.
Subcommittees will report annually to the CSC to provide updates on their activities. Additionally, subcommittees may seek CSC advice on issues, as needed. Subcommittees may be added or terminated by the CSC Chair or by vote of the CSC.
Current Standing Subcommittee:
4.3.1 Regulatory Science Subcommittee
- Co-Chairs: Directors of OSB and OSEL
- Charge: Proactively enhance medical device innovation, development, safety, quality, and efficacy.
5.1 CSC MEETINGS
5.1.1 Meeting Development and Management
- The CSC Executive Project Manager manages the development, scheduling, and conduct of CSC meetings. This includes leading and aiding presentation teams through their development of the meeting and supporting materials.
- The Assistant Director for Science oversees the work of the CSC Executive Project Manager, advises presentation teams throughout the meeting development process, and has the authority to approve ad hoc CSC members.
- A standing appointment will be established in advance on CSC members’ calendars for CSC meetings twice per month with the exception of holiday timeframes.
- Calendar invitations will be updated at least four weeks prior to each meeting with information about the meeting topic.
- If a meeting is not planned for a reserved date, the calendar invitation will be kept on CSC member schedules until 5 working days prior to the meeting to accommodate ad hoc CSC meetings.
5.1.3 Attendance and Participation
- CSC members are expected to participate in all CSC meetings, either in the meeting room or via remote connection.
- For membership positions that require a designated alternate, the alternate is expected to attend CSC meetings that the member is not able to attend.
5.1.4 Meeting Topics
- Anyone in the Center may propose a meeting topic through the process outlined in the Recommending a Topic to the Center Science Council for Discussion SOP.
- All meeting topics will be approved by the Senior Leadership team or its designee, the CSC Chair.
5.1.5 Meeting Schedule
- The schedule of meetings will be determined by the CSC staff and reviewed by the CSC Chair.
- Ad hoc CSC meetings to address urgent public health issues may be held at the discretion of the CSC Chair.
5.1.6 Meeting Materials
- Agendas will be developed by the CSC staff and the presenters, and reviewed by the CSC Chair.
- Meeting materials (e.g., presentation slides, background materials) will be reviewed by the CSC Chair and circulated at least 5 business days prior to each meeting, or as soon as possible for ad hoc meetings.
- The CSC staff will write meeting minutes of all CSC meetings.
- Draft minutes will be circulated to each meeting’s presenter(s) for review for completeness and accuracy.
- Final meeting minutes will be posted for Center-wide viewing.
- Formal voting will be used when considering the use of the Immediately In Effect guidance process, voting on the CSC charter and amendments, and at the discretion of the CSC Chair.
- The Center Director and the CSC staff are non-voting CSC members; all other CSC members are voting members. Ad hoc members may vote, at the discretion of the CSC Chair.
- Voting members are expected to vote when voting occurs during a CSC meeting. The option to abstain from a vote is available, but should be exercised sparingly.
- In the absence of a voting member who has a designated alternate, the alternate may vote.
- A quorum must be present for a vote to occur. A quorum is defined as two-thirds of the voting membership. When calculating two-thirds of the voting membership, a fraction will be rounded down to the whole number. Members may be present in person or via a remote connection to the meeting.
- Formal CSC decisions will be made by a two-thirds majority vote of a quorum. When calculating two-thirds of a quorum, a fraction will be rounded down to the whole number.
- If the CSC cannot reach a decision through a vote within the allotted time frame, or if a quorum is not present, the CSC Chair has the option to make the decision.
- The Center Director has the option to override a decision made by the CSC or the CSC Chair. If this occurs, the Center Director will draft a memorandum to the CSC explaining the basis for the decision. At the CSC’s request, the Center Director may discuss the decision and rationale with the CSC.
- Final CSC decisions will be communicated to affected stakeholders through the appropriate mechanism(s), such as meeting minutes, Center-wide announcements, or external communications.
- For most topics, a formal vote will not be taken. However, informal polling may occur as part of the discussion during meetings.
5.2 CHARTER REVISIONS
Amendments to this charter may be proposed to the Assistant Director for Science or to the CSC Executive Project Manager. The CSC staff will review the charter every two years and revise it as needed, taking into consideration all amendments that have been proposed during the two years preceding the review. Adoption of amendments to the charter requires a two-thirds majority vote by a CSC quorum.