Share profile
Band 5
Provided by Michele Buenafe
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.
The George Washington University Law School, 2005, J.D., High Honors
University of Arizona, 1999, B.S.
Provided by Chambers
Provided by Chambers
Michele brings a pragmatic, in-depth view on complex regulatory matters, drawing on significant experience to help guide the client.
Michele brings a pragmatic, in-depth view on complex regulatory matters, drawing on significant experience to help guide the client.