December 8th, 2011
Posted by Patti Doherty, R.N.
Recent draft polices from the FDA’s Center for Devices and Radiological Health (CDRH) have created concern by industry members that they have been left out of the “network of experts,” a program to supplement the FDA’s existing expertise and to expedite the review process. Despite the fact that the FDA has more than 800 scientists, engineers and clinicians, the agency believes that it is impractical to expect CDRH staff to keep current with so many new and complex technologies surfacing.
The network of experts is designed to be a resource for CDRH, particularly to address questions on emerging and unfamiliar technologies. The outside organizations that are being considered by CDRH for inclusion in the network “…will include professional scientific and medical organizations and academic institutions.” Even though we have not yet heard what organizations the FDA will use in a pilot program to assess their new process, a number of organizations are interested in participating in the program. Industry also would like a seat at the table. Read the rest of this entry »