March 31, 2011
1. What is the Center Science Council?
The Center Science Council (CSC) is a newly established body that will provide oversight of CDRH’s science programmatic functions and help share knowledge throughout the Center, consistent with other ongoing efforts to improve internal communication, consistency, transparency, and quality in scientific decision making, and predictability of regulatory pathways and requirements.
2. Why did CDRH decide to establish Center Science Council?
CDRH’s 2011 Action Plan for 510 (k) and Utilization of Science in Regulatory Decision-Making included the formation of such a council to help the CDRH meet its two public health goals of facilitating innovation and assuring that medical devices are safe and effective. CDRH established the CSC in order to better identify and incorporate new and evolving science and technology into regulatory decision making and to better share and utilize scientific information and knowledge that exists throughout the Center.
3. What are the responsibilities of the Center Science Council?
The CSC is responsible for:
- Identification and incorporation of new and evolving science and technology into regulatory decision making
- Issues related to clinical data and clinical trials
- Management and oversight of the Innovation Pathway
- Quality assurance of Center’s scientific programmatic functions
- Oversight and prioritization of important public health issues that involve or impact multiple CDRH disciplines and offices.
4. How will the CSC help CDRH identify and incorporate new science into regulatory decision making?
The CSC will help CDRH incorporate new and evolving science into regulatory decision making by:
- Identifying new science and technology relevant to the Center’s mission
- Determining the appropriate Center response to new science and technology, including the establishment of new policy, engagement of external experts or stakeholders, or formation of an internal working group or task force.
- Monitoring appropriateness, consistency, transparency, effectiveness, and efficiency of CDRH’s response to new science and technology;
- Identifying CDRH’s scientific priorities
5. How will the CSC help CDRH with issues related to clinical data and clinical trials?
The CSC will help CDRH with clinical data and trials by providing oversight of clinical data requirements and clinical trial policy and decision making by establishing standard operating procedures or policies that promote appropriate, consistent, and transparent decision making. For example, the CSC may:
- Establish criteria for permitting or denying approval of first-in-human trials
- Develop a Device Feasibility Study Program that safely facilitates iterative device design modifications based on outcomes of pre-clinical testing and early human trials
- Establish policies and criteria for timely supervisory review of pre-IDE and IDE decisions
- Promote the development of higher quality IDE submissions
- Foster the incorporation of under-represented populations into device trials
- Serve as a resource for staff seeking advice on clinical trial design
- Determine the need for change to premarket or postmarket clinical data requirements, including clinical trials designs, based on new scientific information
6. How will the CSC help CDRH with management of the Innovation Pathway?
The CSC will help manage the Innovation Pathway by supervising its implementation and providing continued oversight, including:
- Establishment of criteria and process for products applying for the Innovation Pathway
- Assessment and selection of product applications for the Innovation Pathway
7. How will the CSC help with quality assurance of the Center’s programmatic functions?
The CSC will help with quality assurance by:
- Promoting the development of metrics to monitor the performance of CDRH’s scientific programmatic functions
- Conducting audits of CDRH scientific programs and decisions to assess appropriateness, effectiveness, efficiency, and consistency
- Providing recommendations for improvements to CDRH scientific programs
8. How will the CSC oversee certain important public health issues?
The CSC will prioritize, manage and help address important public health issues that involve or impact all 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. CSC Staff will work with appropriate CDRH and FDA staff, and external stakeholders to:
- Identify and facilitate the information collection and analysis
- Conduct risk assessments where appropriate
- Supervise action plan development and implementation
- Monitor and track issue management
9. How will the CSC facilitate innovation?
The CSC will facilitate innovation by providing oversight and supervision to the Innovation Pathway, including selection of eligible products. The CSC will also promote innovation by facilitating the incorporation of new science and technology more quickly into regulatory decision making.
10. Who will be on the CSC?
The CSC will be comprised of senior managers and experienced staff from across the Center.
11. Can non-FDA staff participate on the CSC?
No. The CSC is comprised only of FDA employees.
12. To whom will the CSC report?
CDRH Deputy Center Director for Science William Maisel, M.D., M.P.H. will chair the CSC, and CDRH Associate Director for Science, Michelle McMurry-Heath, M.D., Ph.D. will serve as vice chair. CSC decisions and recommendations are subject to review by the CDRH Director, Jeffrey Shuren, M.D., J.D.
13. How will the implementation of the CSC benefit health care providers and consumers?
The Center Science Council will benefit health care providers and consumers by helping CDRH better utilize new and evolving science, which will improve the quality of our decisions and programs and support CDRH’s public health goals of facilitating innovation and assuring that medical devices are safe and effective.
14. Why is the charter being issued in draft form?
The charter is in draft form until the CSC votes to make it official.
15. When will the CSC begin meeting?
The inaugural CSC meeting will be held in April 2011.
16. Biostatistics is a critical component of Clinical Study Design and key to the success or failure and any clinical trial. There does not seem to be a statistician on the CSC or the Innovation Pathway Committee. Can you clarify?
There is statistical expertise on the CSC and on the Innovation Pathway and Clinical Trial/Clinical Data subcommittees. For particular issues that require additional statistical input, we will be sure to invite appropriate statistical experts to the CSC meeting.
17. How do I get information about the Center Science Council?
For inquiries and comments about the Center Science Council send a message to email@example.com