Shelby Buettner advises pharmaceutical, medical device manufacturers, healthcare technology companies and healthcare providers on FDA regulatory and compliance matters. She regularly counsels clients on regulatory and policy considerations associated with mobile medical technology, telehealth, telemedicine, digital health and clinical research. Shelby assists clients, including academic medical centers and biotechnology manufacturers, with regulatory, transactional and compliance issues related to clinical research, manufacturing and quality issues and legislative initiatives affecting the healthcare industry. Shelby’s transactional practice focuses on advising investors on FDA regulatory and business considerations in pharmaceutical, medical device and clinical research transactions and contractual arrangements. She also assists investors and companies to conduct due diligence on FDA regulatory matters for mergers and acquisitions and other transactions.
Previously, Shelby coordinated the development, validation and regulatory approval of miniature surgical robotic devices. She has experience with clinical outcomes and effectiveness research related to biologics, general surgery, and minimally invasive surgery as well as navigating complex animal and human research infrastructures at academic medical centers and federal agencies. Shelby has managed biomedical development projects with the US Department of Defense (DOD), National Aeronautics and Space Administration (NASA) and has conducted research with the United Nations Environmental Programme.
Shelby has authored many articles appearing in publications such as BNA’s Health Law Reporter, American Journal of Surgery, Journal of Robotic Surgery, Urologic Clinics of North America, Surgical Endoscopy and Administrative Theory & Praxis.
cum laude, 2015
cum laude, 2015