Michele Buenafe
USA Guide 2024
Band 5 : Healthcare: Pharmaceutical/Medical Products Regulatory
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Band 5
About
Provided by Michele Buenafe
Practice Areas
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.
Personal
The George Washington University Law School, 2005, J.D., High Honors
University of Arizona, 1999, B.S.
Chambers Review
USA
Michele Buenafe serves as the firm's digital health team leader and healthcare industry team co-leader. Clients turn to her for FDA regulatory compliance and enforcement issues. She is especially known for her expertise in digital health-related issues.
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Morgan, Lewis & Bockius LLP
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