CDRH Unveils Plan to Leverage Outside Expertise

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with faster access to specific specialized knowledge about emerging technology, as well as other topics.

CDRH plans a pilot program of the network through Dec. 30.

Although the agency’s device center already has a staff of scientists, engineers and clinicians, the FDA often draws on external expertise in reviewing products, especially in areas where knowledge can change rapidly. One of the criticisms that industry recently has had about FDA’s medical device review program is that medical device technology evolves too quickly for the agency to keep up with all the change. Creating an impartial outside panel could aid CDRH staff in addressing the iterative nature of device technology. Experts in the pilot program will not provide policy advice or opinion but will help center staff form their own conclusions, according to agency leadership.

The program is part of the FDA’s efforts to reform its 510(k) approval process for medical devices. In recent years the agency’s devices unit has been dogged by high staff turnover, funding woes and major recalls. This summer, the Institute of Medicine, in a report to the FDA, said 510(k) did not adequately protect patients and recommended a more thorough process that would likely raise the costs for device makers.

“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,” William Maisel, M.D., CDRH deputy center director and chief scientist. “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.According to CDRH officials, 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.

“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,” Maisel added.

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 that CDRH is seeking to build the network. The Expert Utilization SOP describes how CDRH staff will access and interact with 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.

“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, adding that this will permit a “fast and efficient exchange” of knowledge with scientific leaders on an as-needed basis.

The public comment period will run through Oct. 28.