FDA to Tap Outside Specialized Experts on Devices

(FDA.gov)

The Food and Drug Administration announced plans to form a new network of outside experts to offer specialized advice on medical devices. The FDA is also seeking public comment on draft procedures for recruiting and operating this network.

FDA’s Center for Devices and Radiological Health (CDRH), the part of the agency that regulates medical devices, says it needs the proposed network to supplement its current staff of scientists and engineers, as well as its advisory panels. The center, says FDA, sometimes needs help with rapidly advancing technologies used in increasingly complex devices.

A key purpose for the network is to provide timely advice. CDRH says it cannot be sure that an expert in an emerging technology on an advisory panel will be available when that expertise is needed. Other 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.

FDA says the CDRH Network of Experts, as it is called, would allow staff to tap into a vetted network of scientists and engineers for detailed scientific information. Members of the network 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.

CDRH plans to build the network in partnership with scientific, academic, and clinical organizations. The center will enter into agreements with these organizations and then call upon their membership for needed expertise to permit the exchange of knowledge.

The proposed plan for the network consists of two draft standard operating procedure (SOP) documents: the Expert Enrollment SOP and the Expert Utilization SOP. Both documents will be available for public comment from 6 October through 28 October 2011. CDRH will also conduct a 12-week pilot test of the network through 30 December 2011.

Read more: FDA Issues Regulatory Science Modernization Plan

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