FDA district classification of Class II/III recalls being tested in reengineering pilot.
This article was originally published in The Gray Sheet
Executive Summary
CLASS II/III RECALL CLASSIFICATION AT DISTRICT LEVEL will be tested by FDA's Boston District Office under a recall process reengineering pilot scheduled to commence in June. The program is intended to help the agency make more efficient use of resources by shifting classification responsibility for Class II and Class III recalls from the Center for Devices and Radiological Health to field office recall coordinators, the staffers who currently make recall classification recommendations to CDRH. CDRH will retain responsibility for processing Class I recalls.