CDRH Reorganizes its Office of Device Evaluation

By Jennifer D. Newberger –

CDRH recently announced that, as of November 1, 2012, the Office of Device Evaluation ("ODE") has been reorganized.  There are two new divisions—the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices—and 12 new branches across all seven review divisions. 

CDRH stated that the intent behind the reorganization is to “reduce the manager to staff ratios and better align product areas as well as accommodate the new MDUFA hires that will be coming into the Center.”  CDRH has hired some staff to help fill the newly created manager positions, though “it is anticipated that a good portion of the positions will likely be filled with existing staff.”  Until new staff is in place, CDRH “did not want to create voids in the review positions that would impair [its] ability to meet performance goals.”  In the coming weeks, CDRH will be advertising and interviewing to fill the new positions.

In addition to the new divisions and new branches, FDA will also shift the responsibility for reviewing “30-day notices” regarding changes to cardiac devices from the Office of Compliance to ODE’s Division of Cardiovascular Devices.  This change is expected to take place beginning January 1, 2013.