Christy Foreman, MBE

Christy Foreman, MBE

Senior Consultant

Ms. Foreman comes to Biologics Consulting in 2018 with over 28 years of federal service. She has
22 years of experience with the Food and Drug Administration (FDA), 18 of those years spent in the Center for Devices and Radiological Health. She has extensive experience with premarket regulatory programs (PMAs, 510(k)s, de novo applications, IDEs and pre-submissions) and well as good manufacturing practices including the Quality System Regulation and postmarket enforcement issues such as recalls, warning letters, seizures and injunctions for a wide variety of medical devices.

Christy began her career at the FDA in 1996 as a reviewer in the anesthesiology and defibrillator devices branch in the Office of Device Evaluation (ODE) where she also began serving as an FDA representative on several voluntary consensus standards for medical devices. She entered management as the Branch Chief for orthopedic, physical medicine and anesthesiology devices in the Office of Compliance. She went on to become the deputy division director in the Office of Compliance for the division responsible for orthopedic, physical medicine, anesthesiology, cardiovascular, neurology and radiology devices. She then returned to ODE where she served as the deputy office director from 2008 – 2010 and the director of ODE from 2010-2014. She was instrumental in the development and implementation of the 510(k) plan of action, implementation of new legislation such as FDASIA and user fee negotiations within industry.

In 2014 Ms. Foreman joined the Center for Tobacco Products as the Associate Director for Regulatory Programs in the Office of Compliance and Enforcement where she developed new regulatory programs and regulations, including manufacturing regulations, in the newest Center in the FDA.

Christy received her BBE in Biomedical Engineering in 1993 and her MBE in Biomedical Engineering in 2000, both from The Catholic University of America.


Education

M.B.E. Biomedical Engineering, The Catholic University of America, Washington, DC (2000)

B.B.E. Biomedical Engineering, The Catholic University of America, Washington, DC (1993)