Center for Devices & Radiological Health veteran Timothy Ulatowski will assume the position of Office of Compliance director starting Jan. 22, pending final sign-off by FDA Commissioner Mark McClellan.

Currently director of the Division of Anesthesiology, General Hospital, Infection Control & Dental Devices (DAGID) within the center's Office of Device Evaluation, Ulatowski has been with the agency since 1974 and has held various ODE positions since 1980.

Key projects on which Ulatowski has worked include Global Harmonization Task Force initiatives to better harmonize FDA regulations with other countries and implementation of reuse provisions mandated by the Medical Device User Fee & Modernization Act, enacted in October.

OC has lacked a permanent director since June 2000, when then-OC Director Lillian Gill was named acting deputy director of science. She subsequently assumed the role of CDRH senior associate director.

Deputy Director Larry Spears currently is acting director of OC. Spears was named to the interim position following the December retirement of Philip Frappaolo, who also served as acting director of the office.

OC recently pared down its three-division structure to two enforcement divisions: DOE A and DOE B (¹ Also see "OC Director Appointment Expected In Early 2003; Reorganization Wrapping Up" - Medtech Insight, 9 December, 2002., p. 8). It remains to be seen whether further organizational adjustments will be made once Ulatowski takes the helm.

As director of DAGID, Ulatowski recently oversaw structural changes in his division when the anesthesiology and respiratory device branch was transferred from the cardiovascular division of ODE to DAGID (² Also see "CDRH Premarket Division Reviews Mulled By ODE Incoming Director Schultz" - Medtech Insight, 19 August, 2002., p. 3). The move had been in the works for several years as a way to help balance workload across ODE divisions (³ Also see "Respiratory Device Hand-off To FDA Dental Group Intended To Achieve Parity" - Medtech Insight, 9 August, 1999., p. 4).

Current DAGID Dental Devices Branch Chief Susan Runner will serve as acting director of DAGID when Ulatowski moves to OC later this month.

ODE Division Director Ulatowski Appointed Office Of Compliance Chief

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