DENNIS C. GUCCIARDO is a partner at Morgan, Lewis & Bockius LLP, where he counsels domestic and global medical device manufacturers to help ensure they are operating in compliance with the myriad of US Food and Drug Administration (FDA) regulations, requirements, and expectations. He works with companies—from small startups to large multinational corporations—throughout the product life-cycle on how to bring novel technologies to market, maintain compliance, and avoid FDA enforcement actions. Dennis helps companies bring medical devices to market, including navigating the premarket process, establishing a quality system, and complying with postmarket requirements. Recently, in response to the coronavirus (COVID-19) global pandemic, Dennis assists companies (traditional medical device manufacturers and new market entrants) with navigating FDA enforcement policies and the Emergency Use Authorization (EUA) process for quickly bringing products to market. When FDA action does occur, Dennis works with companies to develop risk-based and right-sized action plans to address FDA concerns, including responding to FDA Form 483 inspectional observations, untitled letters, and FDA warning letters; FDA-requested certified audit programs; and preparing medical device recall plans.