By Jim Dickinson

CDRH Office of Device Evaluation (ODE) director Christy Foreman is stepping down effective September 7, 2014, to accept a new position as associate director for regulatory programs in the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products.

According to a brief agency announcement, CDRH deputy director for science and chief scientist William Maisel will serve as ODE’s acting director while a search for a permanent replacement for Foreman is conducted.

ODE is the largest office in CDRH and has recently reorganized into seven reviewing divisions covering numerous medical specialties including cardiovascular, orthopedic, surgical, neurological, anesthesiology, gastro-renal, and ophthalmic.

The office is responsible for reviewing premarket applications and approving clinical studies for medical devices. Before being named to the director position, Foreman served as ODE’s deputy director for science and regulatory policy.

She also worked in the CDRH’s Office of Compliance for seven years and before that spent five years as a reviewer in the anesthesiology and defibrillator devices group within ODE. Before joining FDA, Foreman spent seven years at the Naval Medical Research Institute in Bethesda, MD, with specific research areas in environmental physiology and neuropharmacology.

Jim Dickinson is MD+DI's contributing editor.

[image from MD+DI archives]