CDRH Sets Up Pilot Program on Establishing Panel of Outside Experts
The US FDA’s Center for Devices and Radiological Health (CDRH) has launched a 12-week pilot program on its proposed CDRH Network of Experts, a panel of outside scientific experts to provide more specialized knowledge about emerging medical device technologies in order to expedite medical device reviews.
According to the CDRH, the outside panel will only provide information and expertise on particular issues, not actual policy advice. The network would be formed through partnerships with scientific, academic and clinical organizations.
The CDRH Network of Experts plan comprises two standard operating procedure (SOP) documents: the Expert Enrollment SOP covering how collaboration agreements will dictate interactions between outside experts and CDRH staff, and the Expert Utilization SOP governing how staff will engage with outside experts as well as safeguards to address confidential information and conflicts of interest.
The Network of Experts proposal was one of 25 510(k) and Science Recommendations intended to boost regulatory predictability and transparency.
The pilot program will last until December 30; CDRH is also seeking public comment through October 28.