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U.S. Department of Health and Human Services

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Network of Experts - Expert Enrollment Standard Operating Procedure (FINAL)

An SOP on the selection and enrollment of organizations for the Center for Devices and Radiological Health (CDRH) Network of Experts.

This SOP outlines the criteria and process for selecting scientific, engineering, and clinical organizations for the Network of Experts. The Network and the process for soliciting Network expertise is described more fully in the accompanying SOP "Network of Experts - Expert Utilization Standard Operating Procedure (DRAFT)."

Mechanism

CDRH’s Network of Experts will be facilitated through a series of agreements with non-profit, academic, and professional societies with membership expertise in topics of relevance to the mission of CDRH. Agreements will be established with individual eligible organizations such that the partnership can be used to address a variety of questions over a 2-3 year period. However, the topics will be highly focused or restricted to a specified area of science or medicine, predicated on the intellectual contributions of the organizations selected.

Conflicts of interest- actual or apparent- will be addressed in the review and approval of the agreements. Further, each agreement will be constructed to be consistent with FDA’s mission.

Partnership Organization Selection

Expertise – CDRH’s goal is to include the most prominent scientific experts in the Network. For that reason, preference will be given to organizations whose membership has been screened for their scientific and/or professional achievements (e.g. honorific societies, educational organizations, and professional societies). Members of the organizations should be well established in their respective disciplines and be able to assist in addressing questions in new and emerging fields of science and pioneering technologies. CDRH intends to partner with scientific and clinical organizations that represent major public health concerns, whose mission intersects with the scientific and regulatory mission of CDRH, and whose membership includes scientific and clinical leaders. CDRH aims to include a variety of viewpoints in the Network.

CDRH intends to give preference to organizations, such as 501(c)(3) organizations and other non-profits, whose primary function is not lobbying or sector promotion. Input from patient and consumer advocacy organizations is valued within CDRH, but is unlikely to be consistent with the goals or structure of the Network of Experts.

Preference will be given to organizations that meet the above standards and are nominated by CDRH staff as described below.

Nomination - Organizations for the Network of Experts will be selected by CDRH staff. Any member of the CDRH staff can nominate an organization for the Network of Experts by submitting the name of the organization, a brief description of their relevant expertise, and any known contact information to the Network of Experts coordinator. Final selection will be made by the Center Science Council or the Associate Director for Science.

Partnership Organization Enrollment

Once an organization is selected for the Network by CDRH staff, agreements will be drafted and negotiated by the technology transfer staff in CDRH. Once an appropriate agreement has been negotiated and is executed, the organization will be considered enrolled in the Network of Experts.