Michele L. Buenafe


Michele L. Buenafe counsels clients on US Food and Drug Administration (FDA) compliance and enforcement matters related to medical devices and combination products, and also advises on US Drug Enforcement Administration (DEA) and state regulatory issues for controlled substances and medical products, including both drugs and devices. In addition, she advises clients on emerging legal issues relating to digital health platforms, such as mobile medical apps, clinical decision support software, software as a medical device (SaMD), telemedicine systems, wearable devices, and other health information technology. Michele serves as the leader of the firm’s digital health initiative and as co-leader for the firm’s cross-practice healthcare initiative.