Dennis C. Gucciardo 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. When multiple sites are implicated, Dennis assists in preparing and executing global remediation plans to help ensure that all company sites act in accordance with company expectations and FDA requirements.
Dennis also assists in the defense of criminal investigations and conducts internal investigations of alleged regulatory violations. Additionally, he works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions. He has been involved in numerous transactions ranging from multibillion-dollar acquisitions to the negotiation of supply and distribution agreements.
Dennis is a frequent speaker on regulatory compliance and enforcement issues in the device industry, and his pro bono work involves representing inmates before the US Parole Commission as part of the Washington Lawyers’ Committee DC Prisoners’ Project.
Before joining Morgan Lewis, Dennis was counsel at another global law firm.
Recommended, Industry focus: Healthcare: life sciences, The Legal 500 US (2022)
Up-and-Coming, Healthcare: Pharmaceutical/Medical Products Regulatory, District of Columbia, Chambers USA (2021, 2022)
Recognized, DC Trailblazer, The National Law Journal (2020)
Executive Editor, Florida Law Review, University of Florida
Member, Journal of Technology Law and Policy