Michele L. Buenafe

パートナー

Washington, DC 電話 +1.202.739.6326 Fax +1.202.739.3001

1111 Pennsylvania Ave. NW//Washington, DC 20004-2541//United States

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.

In addition, she advises clients on emerging legal and regulatory issues relating to SARS-CoV-2 tests and other COVID-19-related medical devices, including FDA review and oversight, CLIA regulation, the PREP Act, and related state laws and regulations.

Michele works with a variety of medtech companies – from large, multinational medical device and technology companies to small startups and software developers – on a broad range of issues across the product life-cycle, including premarket pathway strategies, clinical study submissions and compliance, quality system regulation (QSR) compliance, FDA registration and listing, product recalls, inspections, import alerts, and medical device reporting.

Michele also advises on issues relating to the federal Controlled Substances Act, 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.

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.

Selected Representations

Assisted in responding to FDA, DEA, and state enforcement correspondence, including FDA 483s, Warning Letters, untitled letters, and state board inquiries.
Addressed all forms of FDA and DEA regulatory issues and related state compliance matters in M&A transactions involving FDA and DEA regulated products (e.g., medical devices, digital health technologies, pharmaceuticals, and controlled substances), including regulatory due diligence, compliance representations and indemnification, and structured payments for achieving regulatory milestones.
Handled all forms of transactional agreements, including purchase and supply, clinical trial, co-marketing, contract manufacturing, distribution, and quality agreements.
Supported a leading US device manufacturer during an FDA inspection and in responding to a subsequent FDA Form 483, preparing for a meeting with FDA to discuss planned corrective/preventative actions, preparing periodic monthly updates to FDA, responding to FDA written inquiries, and during follow up FDA inspections.
Advised a large technology company on the regulatory status of and potential premarket pathway options for a wearable device and associated software; assisted in preparing clinical study protocols, informed consents, and IRB submissions for the same technologies; provided training on clinical study compliance requirements; reviewed draft FDA premarket submissions; and advised on ongoing clinical study compliance issues.
Assisted companies to evaluate risks associated with 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 clients on the applicability of the 21st Cures Act software exemptions to clinical decision support software, artificial intelligence/machine learning software, and mobile medical apps.
Advised multiple US device manufacturers on the review of promotional materials, and served as a member of the promotional review committees.
Assisted a US device manufacturer in successfully lifting an import alert for one of its foreign contract manufacturers that resulted from an unsuccessful FDA inspection of the contract manufacturer.
Assisted in responding to FDA “It has come to our attention letters” and negotiating with FDA on device jurisdictional issues.
Provided advice to clients on issues related to genetic testing, including FDA requirements and exemptions and state law restrictions.