Tuesday, October 04, 2011

News from the FDA: FDA Outlines Plans for an Outside Network of Scientific Experts

A press release from the FDA:

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

04 October 2011

"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."

To read the full release click here.

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