Michele L. Buenafe counsels clients on US Food and Drug Administration (FDA) compliance and enforcement matters related to medical devices, combination products, and digital health technologies, such as software as a medical device (SaMD), telemedicine systems, clinical decision support software, wearable devices, artificial intelligence systems, and mobile medical apps. She also advises on US Drug Enforcement Administration (DEA) and state regulatory issues for controlled substances and medical products, including both drugs and devices. Michele serves as the leader of the firm’s digital health team and as co-leader for the firm’s cross-practice healthcare industry team.
In addition, she advises clients on emerging legal and regulatory issues relating to SARS-CoV-2 tests and other COVID-19-related medical devices, including FDA review and oversight, CLIA regulation, the PREP Act, and related state laws and regulations.
Michele works with a variety of medtech companies – from large, multinational medical device and technology companies to small startups and software developers – on a broad range of issues across the product life-cycle, including premarket pathway strategies, clinical study submissions and compliance, quality system regulation (QSR) compliance, FDA registration and listing, product recalls, inspections, import alerts, and medical device reporting.
Michele also advises on issues relating to the federal Controlled Substances Act, DEA regulations, and state regulatory requirements for clients including drug and device manufacturers, wholesale distributors, pharmacies, healthcare providers, and manufacturers of controlled substances and listed chemicals.
Michele actively participates in the Food and Drug Law Institute/FDA In-House Training Program and is a frequent speaker at medical device and digital health industry conferences.
Prior to joining Morgan Lewis, she worked at a consulting group, where she assisted on matters involving cGMP compliance. Michele has a degree in chemical engineering.
Leadership Council on Legal Diversity Fellow (2020)
Next Generation Partner, Industry focus: Healthcare: life sciences, The Legal 500 US (2019–2022)
Recognized, FDA Law, Washington, DC, The Best Lawyers in America (2022)
Named, Modern Healthcare’s “Largest Healthcare Firm” (2016–2021)
Recommended, Industry focus: Healthcare: life sciences, The Legal 500 US (2017–2020)
Life Sciences Star, Regulatory, LMG Life Sciences (2016–2021)
DC Rising Star, The National Law Journal (2017)
Member, Women’s Leadership Council for the American Health Lawyers Association (2017–2020)
Member, Food & Drug Law Institute Medical Devices Committee, (2013–2016)
Member, Food & Drug Law Institute Editorial Advisory Board, Update Magazine (2010–2012)
Staff Member, American Intellectual Property Law Association Quarterly Journal (2003–2005)