Michele L. Buenafe
Michele L. Buenafe is leader of the Morgan Lewis FDA and healthcare practice, leader of the firm’s digital health team, and co-leader for the firm’s life sciences industry team. Michele counsels medical device and digital health clients on a wide range of regulatory, compliance, and enforcement issues concerning US Food and Drug Administration (FDA) requirements, the federal Clinical Laboratory Improvement Amendments (CLIA), and corresponding state laws and regulations. Michele also has extensive experience advising companies on post-market compliance matters across FDA-regulated product areas, including human tissues, biologics, foods, and drugs. In addition, she counsels clients on US Drug Enforcement Administration (DEA) and state requirements governing controlled substances and listed chemicals.
Michele works with a variety of medtech companies—from large, multinational medical device and technology companies to small startups, clinical laboratories, and software developers—on a broad range of issues across the product lifecycle, including premarket pathway strategies, clinical study compliance, digital health and software regulatory issues, FDA premarket submissions and review, quality management system regulation (QMSR) compliance, establishment registration and listing, medical device reporting, product recalls, facility inspections, and import alerts. She also advises on the intersection of FDA requirements with CLIA and state laboratory, device, and other regulatory requirements.
A significant focus of Michele’s practice is post-market compliance across FDA-regulated product areas. She supports a wide variety of clients, including testing and research laboratories; manufacturers and contract manufacturers; distributors, dispensers, and retailers; suppliers of components, parts, and raw materials; and sterilization facilities. Michele advises clients on the full spectrum of compliance issues, including recalls and related field actions, FDA inspections, FDA 483s and Warning Letters, current good manufacturing practice (cGMP) and QMSR issues, quality investigations, and other internal investigations. Clients also consult with Michele for support on high-stakes FDA enforcement actions, recalls, and other crisis management.
Michele has substantial experience with the federal Controlled Substances Act, DEA regulations, and related state requirements. She advises a variety of clients on issues including DEA registration, state licensing, security, recordkeeping, theft/significant loss investigations, reporting, distribution, and other regulatory and compliance requirements.
Michele is a frequent speaker at medical device and digital health industry conferences and has participated in the Food and Drug Law Institute/FDA In-House Training Program.
Prior to joining Morgan Lewis, she worked at a consulting group, where she assisted on matters involving pharmaceutical cGMP compliance. Michele has a degree in chemical engineering.
