Ryan counsels domestic and global companies regarding products that are regulated by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Alcohol and Tobacco Tax and Trade Bureau (TTB), and relevant state agencies. Clients seek Ryan’s counsel on a variety of regulatory and legal issues, including regulatory compliance, government inquiries, inspections, enforcement actions, food safety compliance, product life-cycle development, and transactional matters impacting the food and medical device industries.
Ryan’s experience extends to working with clients with new and emerging technologies, such as the at-home meal and online grocery delivery industries, companies involved in the life science industries, and those involved with various digital health platforms, such as mobile medical apps, software as a medical device (SaMD), telehealth, wearable devices, and other health technologies. During the coronavirus (COVID-19) pandemic, Ryan assists companies navigating the FDA’s enforcement policies and helps companies bring products to market through designated pathways as quickly as possible, such as the Emergency Use Authorization (EUA) process.
Additionally, Ryan regularly handles issues relating to medical device reporting requirements, regulatory pathway options, market entry, current good manufacturing practices (cGMPs) and quality system regulation (QSR) compliance, and postmarket compliance. He regularly assists all actors in the supply chain, including manufacturers, distributors, and retailers.
- Counsels and assists clients in responding to FDA, USDA, TTB, and relevant state agency enforcement actions, including FDA 483s, warning letters, recalls, import detentions and import alerts, and state board inquiries.
- Assisted a global medical device manufacturer during an extensive FDA inspection and in handling multiple FDA form 483 responses. Provided counsel and assisted with monthly updates to the FDA and assisted company with implementing changes to QSR and medical device reporting (MDR) procedures.
- Supported companies with the development and use of laboratory developed tests (LDTs), including genetic and general wellness applications.
- Advised multiple medical device clients in reviewing promotional materials and labeling.
- Assisted a global company on the requirements of implementing COVID-19 testing in jurisdictions throughout the United States.
- Regularly counsels the animal feed industry on FDA, USDA, and state agency regulatory requirements, including AAFCO policies.
- Address all forms of FDA, USDA, and relevant state agency regulatory issues in M&A transactions (e.g., human and animal food, medical devices, digital health technologies, and other life science products).
- During the COVID-19 pandemic, counseled clients on label declarations and allergen labeling requirements for online food sales and sales made through mobile-order apps.
- Advises global companies and regularly presents on the FDA’s Food Code and state implementations and enforcement.
- Assists companies with the diligence involving the sale and acquisition of companies that produce FDA-regulated products, including human and animal food and medical device companies.
- Successfully led a nontraditional company through its first 510(k) premarket application and FDA clearance.
- Conducted a 50-state survey on how states define and regulate foods, dietary supplements, and cosmetics containing cannabidiol (CBD). Identified relevant state enforcement activities and risks in selling products containing CBD in certain retail outlets.
- Successfully obtained a TTB importer permit and label approvals for an at-home beverage maker for a novel alcohol beverage. Assisted with relevant state agency regulatory requirements.
- Advised a retailer on private-label alcohol product creation and all requirements to bring product to market, including state challenges with three-tier distribution model.
- Advised global company on the litigation risks surrounding label claims on multiple food products.
- Private Law Practice (2012-2021)
- Food and Drug Law Institute (FDLI)
- Editorial Advisory Board, FDLI Magazine
- FDLI Publications Peer Review Committee
- SupplySide West
- Institute of Food Technologists
- Prime Label Consultants
- Medical Device Manufacturers Association (MDMA)
LL.M., Georgetown University Law Center
J.D., Loyola University Chicago School of Law
B.A., The Ohio State University
Bar and Court Memberships
- District of Columbia
- U.S. Court of Appeals for the Eleventh Circuit
Certified per 21 CFR part 117 as a Preventative Control Qualified Individual
Certified Massachusetts Institute of Technology (MIT) xPRO Drug and Medical Device Development: A Strategic Approach
Related News & Insights
- EventPremarket Notification 510(k) and De Novo RequestsFood and Drug Law Institute (FDLI) Introduction to Medical Device Law and RegulationNovember 16, 2021
- ArticleFood and Beverage Policy Trends to Monitor This YearLaw360Bob Hibbert, Ryan Michael FournierJanuary 13, 2021
- AlertLabeling of Foods Comprised of or Containing Cultured Seafood Cells: FDA Requests Public CommentRyan Michael Fournier, Ann M. Begley, Grace Caroline Mahan, Hume M. RossNovember 6, 2020
- AlertFull Speed Ahead – FDA’s Digital Health Center of Excellence to Host Listening SessionsAnn M. Begley, Ryan Michael FournierOctober 16, 2020