About Us Experts Kyle Y. Faget

Kyle Y. Faget

J.D.

Kyle Faget, J.D., is a special counsel and health care and life sciences lawyer with Foley & Lardner LLP.  Kyle regularly represents pharmaceutical and medical device companies in all stages of product development. She advises her clients on any and all legal, regulatory, and policy issues arising in the research context, including compliance with the Food, Drug, and Cosmetic Act (FDCA), Institutional Review Boards (IRBs) and institutional policies governing the conduct of clinical and non-clinical research.  Kyle helps clients move products from the bench to commercialization.  She regularly negotiates basic science research agreements, clinical trial agreements, informed consent forms, and master services agreements.  She also advises clients as they ramp up to commercialization by assisting with implementation of effective corporate compliance programs.  She regularly advises on off-label promotion, compliance with the Anti-Kickback Statute, HIPAA, Investigational New Drug Applications (INDs), 510(k) clearances, pre-market approval (PMA) applications, the regulation of software as a medical device, and mobile medical device applications. Kyle earned her J.D. from University of Michigan and her bachelor's degree from Smith College. She is admitted to practice in Massachusetts.