Dr. Erin Keith is the Director for the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices (DAGRID) in the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health (CDRH). As the DAGRID Director, Ms. Keith provides executive oversight of the division’s premarket programs and review policy for a wide-range of medical device product lines; establishes the division strategic priorities; and supervises a diverse staff of medical, engineering and scientific staff. In her management role in DAGRID, she oversees DAGRID’s implementation of a unique risk-management pilot program, the Safety Assurance Case for Infusion Pumps. She also continues to teach on risk management topics, and represents CDRH in international standards development and harmonization activities.
Prior to her current position with DAGRID, Ms. Keith was the Deputy Director for Science and Policy for the Division of Orthopedic Devices (DOD) in ODE from May 2011 to November 2013. In DOD she provided oversight of the division implementation of review policy and scientific review issues. Additionally, Ms. Keith was the Assistant Country Director for Medical Devices at the US FDA New Delhi Office from February 2009 until May 2011.
As an Assistant Country Director, Ms. Keith was responsible for analyzing the Indian medical device industry’s capabilities for meeting US regulatory requirements and developing a program to increase the Indian industry’s knowledge of US medical device regulatory requirements.