FDA NEWS RELEASE
For Immediate Release: Oct. 4, 2011
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FDA outlines plans for an outside network of scientific experts
Network will help quickly address regulatory concerns, broaden staff knowledge of new and emerging technologies
FDA’s Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To further enrich this comment period, CDRH will also conduct a 12-week pilot of the network through Dec. 30, 2011.
CDRH has a world-class scientific staff that includes scientists, engineers, and clinicians. Nevertheless, there are times when staff must turn to external sources to further enhance their scientific understanding, given the rapid advancements in certain scientific fields, the development of pioneering technologies and increasingly complex medical devices.
The CDRH Network of Experts would allow CDRH staff to tap into a vetted network of scientists and engineers for detailed scientific information on topics related to medical devices.
CDRH already uses outside experts for its advisory panels. But panel membership is limited to a pool of Special Government Employees who must be recruited and enrolled. The Center cannot be assured that an expert in an emerging technology will be available when that expertise is needed. Other traditional sources of external expertise, such as public workshops, conferences and literature may lag behind current research or may not be available when a scientific question arises at CDRH.
“Medical devices continue to become more diverse and complex. The CDRH Network of Experts will help us broaden our existing expertise and expose our staff to a variety of scientific viewpoints, especially on emerging technology,” said William Maisel, M.D., CDRH deputy center director and chief scientist.
Members of the Network of Experts will not provide policy advice or opinions. Instead, network members will share their particular expertise on specific topics to help center staff form their own conclusions.
The proposed plan consists of two draft standard operating procedure (SOP) documents: the Expert Enrollment SOP and the Expert Utilization SOP.
The Expert Enrollment SOP describes how collaboration agreements will be used to govern the exchange of ideas between CDRH and selected experts, and the kinds of partner organizations CDRH is seeking to build the Network of Experts. The Expert Utilization SOP describes how CDRH staff will access and interact with the Network of Experts. This SOP also outlines safeguards designed to protect privileged and confidential information and to ensure relevant conflicts of interest are disclosed and appropriately addressed.
CDRH will build the Network in partnership with leading scientific, academic and clinical organizations. The center will enter into agreements with these organizations and then call upon their membership for needed expertise. This will permit a fast and efficient exchange of knowledge with scientific leaders on an as-needed basis.
“The rules of engagement for this Network of Experts must be appropriate, clear and address potential bias. With this transparency, we believe that our staff will benefit from leveraging external expertise to address emerging scientific questions,” said Maisel.
CDRH will announce the opening of a public docket in a Federal Register notice on Oct. 6, 2011. The docket will be open until Oct. 28, 2011.
The Network of Experts pilot will run from Sept. 30, 2011 through Dec. 30, 2011.
The Network of Experts is one of 25 items in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase predictability and transparency of regulatory pathways and to strengthen the 510(k) process.
For more information:
Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT)
Network of Experts — Expert Enrollment Standard Operating Procedure
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.