In Brief: FDA's Division of General and Restorative Devices
This article was originally published in The Gray Sheet
Executive Summary
FDA's Division of General and Restorative Devices: Office of Device Evaluation division assumes responsibility for all neurological device premarket reviews effective Oct. 1. Formerly reviewed by ODE's Division of Cardiovascular, Respiratory and Neurological Devices, responsibility for the products was transferred to DGRD to prevent any overlap of efforts resulting from the restorative nature of the neurological products, FDAers say. Two DCRND reviewers have moved to DGRD, which will spread the added workload among the four existing branches as appropriate...