Michele L. Buenafe

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 life-cycle, including premarket pathway strategies, clinical study submissions and compliance, FDA and CLIA regulation for laboratory developed tests (LDTs), quality system regulation (QSR) compliance, establishment registration and listing, product recalls, facility inspections, import alerts, and medical device reporting. She also provides counseling on high-stakes FDA enforcement actions, recalls, and other crisis management.

Michele also advises on issues relating to the federal Controlled Substances Act, DEA regulations, and state regulatory requirements for a variety of clients, including drug and device manufacturers, wholesale distributors, reverse distributors and destruction facilities, pharmacies, healthcare providers, and manufacturers of controlled substances and listed chemicals.

Michele actively participates in the Food and Drug Law Institute/FDA In-House Training Program and is a frequent speaker at medical device and digital health 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.

• Served as lead counsel in negotiating a complex Consent Decree on behalf of Philips Respironics and certain of its corporate affiliates with the FDA and the Department of Justice (DOJ) 
• Served as lead counsel for a medical device client in responding to a Section 518(a) order issued by FDA (related to recall notifications) and negotiating with FDA on the proposed issuance of a Section 518(b) Order (related to a plan for device repair/replace/refund activities) 
• Advised multiple companies on premarket regulatory strategies related to various types of medical devices and digital health technologies and provided support for submissions (including 510(k)s, de novo applications, Q-subs, IDE/IRB submissions, and breakthrough device designation requests)
• Assisted in responding to FDA, DEA, and state enforcement correspondence, including FDA 483s, Warning Letters, “it has come to our attention” letters, untitled letters, and state board inquiries
• Advised companies on the development and use of new and innovative technologies, including artificial intelligence/machine learning (AI/ML) software, 3D printing technologies, digital therapeutics, and virtual reality/augmented reality devices
• Advised multiple clients on the applicability of the 21st Cures Act software exemptions and various FDA enforcement discretion policies (e.g., General Wellness, Mobile Medical Apps) for clinical decision support software, AI/ML software, mobile apps, software as a service (SaaS), telehealth/virtual health platforms, and other digital health offerings
• Provided regulatory support for M&A transactions involving FDA and DEA regulated products, including conducting regulatory due diligence and drafting and negotiating compliance representations, indemnification provisions, and structured payments for achieving regulatory milestones
• Drafted and negotiated agreements for all levels of the life sciences supply chain, including manufacturing, quality, distribution, purchase and supply, and clinical trial agreements
• Served as the FDA subject matter expert supporting various medical device litigation matters, including the federal multidistrict litigation (MDL) In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation
• Assisted multiple companies in evaluating their operations and procedures for compliance with the DEA laws and regulations and the corresponding state requirements related to controlled substances and prescription products
• Assisted multiple clients on regulatory strategy and compliance issues related to the development and use of LDTs for various applications, including use in clinical trials, for genetic/genomic testing, and in general wellness applications
• Advised multiple device manufacturers on the review of promotional materials and served as a member of the promotional review committees
• In response to the COVID-19 pandemic, assisted companies (traditional medical device manufacturers and new market entrants) with navigating FDA enforcement policies and the Emergency Use Authorization (EUA) process to quickly bring products to market
• Provided advice to clients on issues related to genetic testing, including FDA requirements and exemptions and state law restrictions