Amy Fowler, RAC, J.D., is an Associate at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, in vitro diagnostic, pharmaceutical, biotech, food, and nutritional supplement industries. Her practice focuses on regulatory and clinical affairs strategies, preparing domestic and foreign submissions, implementing quality systems, and working on the Unique Device Identifier (UDI) regulation. Amy has a 22 year career specializing in FDA regulatory, clinical and quality systems, working in pharmaceuticals and medical devices, including vitro diagnostics.
Amy obtained her law degree in 2009 from Hamline University. Amy has a Bachelor of Science degree in Chemistry from the University of Minnesota, Institute of Technology, and has held her Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society (RAPS) in the United States since 1995. Amy’s experience is extensive and includes time as a senior associate in regulatory affairs and quality systems at 3M Pharmaceuticals, 3M ESPE and the Bioanalytical Technologies Project between 1992-2005.
Her varied regulatory, quality and clinical training and experience was a valuable prelude to law school. In her career she has handled a wide variety of medical device regulatory challenges, including 510(k)s, de novos, technical files, combination products, IDEs, global submissions, MDRs, labeling reviews, establishment registrations and device listings. She led a 3M business to regulatory compliance with the European Union Medical Device Directive; acted as Management Representative for a medical device quality system; and managed FDA and Notified Body inspections. She has also worked on pharmaceutical regulatory matters supporting both chemistry and manufacturing controls (CMC) and clinical aspects of New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and Drug Master Files (DMFs), as well as clinical financial disclosure and the Prescription Drug Marketing Act. She obtained approval of a pediatric indication for a drug/device combination product encompassing a complex delivery system.
While at 3M Amy distinguished herself by winning a number of group and individual awards such as the Malcolm Baldrige National Quality Award, 3M Division Circle of Technical Excellence Award, and 3M Corporate Circle of Technical Excellence Award.