Reorganization of DCRD Unlikely To Affect PMA/510(K) Review Times - FDA
This article was originally published in The Gray Sheet
Executive Summary
The Center for Devices and Radiological Health's reoganization of the Division of Cardiovascular and Respiratory Devices, which will be complete by early September, is not expected to result in review time delays for premarket approval application and 510(k) submissions.
You may also be interested in...
RAPS In Brief
FDA's James Dillard: Deputy Director Bram Zuckerman will become acting director of FDA's Division of Cardiovascular and Respiratory Devices Dec. 3. Current DCRD Director James Dillard departs Nov. 30 for the private sector, where he has accepted the position of VP-science and technology at U.S. Tobacco. Dillard, a fourteen-year FDA veteran, has held the DCRD position for the last 18 months and overseen the reorganization of the division (1"The Gray Sheet" July 24, 2000, p. 10)...
RAPS In Brief
FDA's James Dillard: Deputy Director Bram Zuckerman will become acting director of FDA's Division of Cardiovascular and Respiratory Devices Dec. 3. Current DCRD Director James Dillard departs Nov. 30 for the private sector, where he has accepted the position of VP-science and technology at U.S. Tobacco. Dillard, a fourteen-year FDA veteran, has held the DCRD position for the last 18 months and overseen the reorganization of the division (1"The Gray Sheet" July 24, 2000, p. 10)...
ODE Completes Six-Branch Reorganization Of Cardiovascular Division
The Center for Devices and Radiological Health (CDRH) authorized reorganization of the Division of Cardiovascular, Respiratory and Neurological Devices (DCRD) the week of Nov. 6, making an official transition to a six-branch structure.