Allison Kumar

Allison has more than 15 years of regulatory experience, with 10 years at the FDA and over 5 years in the medical device and biotech industry. At FDA, Allison provided specialized and strategic direction to academia, industry and government partners for alignment of novel, innovative medical device development efforts with regulatory expectations. Allison served as a policy and scientific adviser in several product areas including traumatic brain injury, IVDs, mobile medical apps, advanced physiological monitoring, critical care devices and conducted pre-market reviews for cardiovascular devices and combination products. Allison is currently using the valuable experience and knowledge gained at FDA to advise medical device companies on their regulatory strategies as they pursue marketing approval. Allison has a biomedical engineering degree from Virginia Tech, a graduate degree from Georgetown University in Biothreats and Emerging Infectious Disease, and graduated from the Harvard School of Public Health’s National Preparedness Leadership Institute.