Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers – FDA Watch
In this fourth and final part of our series in collaboration with Covington, Wayne chats with Kristin Davenport, Christina Kuhn, and Olivia Dworkin, Attorneys at Covington; and Jackie Haydock, Chief Healthcare Compliance Officer and Associate General Counsel at Meta. Together, they discuss the evolving landscape of digital health worldwide; FDA’s revised guidance on general wellness as it relates to digital health and consumerism; considerations for consumer product companies as they enter the regulated health space; regulatory challenges with multifunction products; what’s on the horizon for FDA and industry in digital health and AI; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Kristin Davenport
Kristin Davenport advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters, and import/export issues.
She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls, and Part 806 reports.
Kristin regularly prepares 513(g) Requests for Information to obtain FDA’s views regarding the classification and applicable regulatory requirements for novel devices, such as mobile medical applications. She develops successful premarket strategies for clients, and frequently participates in pre-submission meetings with CDRH. Kristin navigates issues that arise during the premarket review process, and has successfully represented device companies in administrative appeals.
She also assists and represents clients in compliance and enforcement proceedings, including responding to FDA Form 483s and Warning Letters.
Kristin advises on jurisdictional questions and assists clients with combination product issues, including submitting Requests for Designation to the Office of Combination Products.
Christina Kuhn
Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.
Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.
Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.
Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.
Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.
Olivia Dworkin
Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance.
With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.
Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.
Jackie Haydock
Jackie Haydock is a digital health lawyer and technology executive currently serving as Chief Healthcare Compliance Officer and Associate General Counsel at Meta, where she leads healthcare compliance for emerging health technologies.
Over her career, she has advised on some of the most complex intersections of healthcare, AI, and medical devices, with previous roles at Microsoft and Zimmer Biomet. Jackie is passionate about helping innovative health technologies reach patients safely and responsibly.
She earned both her J.D. and MBA from Indiana University.
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