Michele L. Buenafe advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling, and advertising of medical devices, human tissue products, pharmaceuticals, controlled substances, listed chemicals, and combination products. She also advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, 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.
Michele’s experience includes issues relating to regulatory pathway options, current good manufacturing practice (cGMP) and quality system regulation (QSR) compliance, US Food and Drug Administration (FDA) registration and listing, product recalls, and medical device reporting requirements. Additionally, Michele advises on issues relating to the federal Controlled Substances Act, US Drug Enforcement Administration (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. She also actively participates in the Food and Drug Law Institute/FDA In-House Training Program and is a frequent speaker at medical device 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.
Assistance in responding to FDA, DEA, and state enforcement correspondence, including FDA 483s, Warning Letters, untitled letters, and state board inquiries.
Addressing all forms of FDA regulatory issues and related state compliance matters in M&A transactions involving FDA regulated products (e.g., medical devices, health IT products, pharmaceuticals, and human tissues products), including regulatory due diligence, compliance representations and indemnification, and structured payments for achieving regulatory milestones.
Handling all forms of transactional agreements, including purchase and supply, clinical trial, co-marketing, contract manufacturing, distribution, and quality agreements.
Providing advice and assistance to a large technology company not previously subject to FDA regulation in connection with an FDA inspection related to its remote monitoring system. Advised on FDA requirements related to product marketing, MDDS requirements, establishment registration, quality systems, complaint handling, and medical device reporting.
Providing routine advice to clients marketing medical image storage and display devices, MDDS devices, and general purpose IT products (including both hardware and software applications) to healthcare customers to assess FDA regulatory obligations and potential premarket pathways.
Review of marketing materials to ensure compliance with FDA requirements, including any applicable approval or clearance.
The George Washington University Law School, 2005, J.D., High Honors
University of Arizona, 1999, B.S.
District of Columbia
Awards and Affiliations
Recommended, Industry focus: Healthcare: life sciences, The Legal 500 US (2017, 2018)