Dennis Gucciardo

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. Recently, in response to the coronavirus (COVID-19) global pandemic, he 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, he 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, he assists in preparing and executing global remediation plans to help ensure that all company sites act in accordance with company expectations and FDA requirements.

He 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.

He 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, he was counsel at another global law firm.

To learn more about Dennis and his experience, please go to: https://www.morganlewis.com/bios/dennisgucciardo