Babita Mahajan

Babita Mahajan is a senior health scientist and infectious disease specialist within CDRH’s Office of Strategic Partnerships and Technology Innovation. In this role, she supports OSCR’s mission to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to prevent shortages of medical devices. With two decades of expertise in developing and regulating in vitro diagnostics (IVDs) in the Office of Blood Research and Review (OBRR) in the Center for Biologics Evaluation and Research (CBER), Dr. Mahajan serves as a subject matter expert on shortages and supply chain challenges related to testing and diagnostics. Her current work portfolio includes developing proactive data-driven interventions and supporting innovation that helps ensure medical device availability and the resiliency of the medical device supply chain; leading stakeholder engagements and data analytics for CDRH’s ethylene oxide Tiger Team, a cross-functional group supporting continued access to sterilize medical devices. Before joining CDRH in 2022, Dr. Mahajan spent two decades in OBRR, CBER, as a subject matter expert on transfusion-transmitted diseases. She has served on several mission-critical committees, workshops, and working groups within CBER. She has also been involved with the development and writing of several guidance documents, including those pertaining to blood screening devices; served on the FDA Institutional Safety Committee; and peer reviewed the medical research programs for the DoD Congressionally Directed Medical Research Programs. Dr. Mahajan received her Ph.D. from the Post-Graduate Institute of Medical Education & Research, Chandigarh, India, with a major in Medical Parasitology and a minor in Microbiology.