IVD Technology
Magazine
IVDT Article Index
Originally Published November 2000
DCLD restructuring
The Division of Clinical Laboratory Devices (DCLD) at FDA's Center for Devices and Radiological Health may soon undergo a change in its structure. Under the terms of a proposed reorganization plan, the number of DCLD branches responsible for reviewing product submissions would increase from three to six.
Each of the existing DCLD branches is expected to be broken up to form two new branches. The proposal calls for the current microbiology branch to be be broken into two branches—one for virology and one for bacteriology. The current immunology branch would be reorganized into one branch for immunology and molecular diagnostics and another for hematology and cytology. And the clinical chemistry branch would be split into one branch that reviews such products as general chemistry devices and lipids and another that reviews glucose tests and drugs-of-abuse tests.
As of press time, a schedule for the restructuring and search for personnel to head the new branches has not been set. However, division officials expect that the restructuring will take place soon.—Susan Wallace
