Dennis C. Gucciardo

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.

• Assisted ventilator, diagnostic test, air purifier, and Personal Protective Equipment (PPE) (e.g., face masks, gowns, and respirators) manufacturers in navigating the ever-changing FDA regulatory regime for quickly getting product to market to aid in the COVID-19 relief efforts
• Represented Airon Corp, a privately held company specializing in high-tech pneumatic life support products, in a collaboration with GE Healthcare, one of the world’s largest healthcare companies
• Assisted a nontraditional medical device company with bringing its first medical device to market
• Assisted in preparing a complex premarket notification, and responding to FDA feedback, concerning a medical device that was the subject of a CDC Health Alert
• Reviewed advertising and promotional materials for compliance with FDA and FTC regulations
• Assisted in the response to an FDA warning letter issued to a global company regarding alleged quality system and medical device reporting violations
• Conducted a review of changes made to a premarket approval (PMA) manufacturing device since approval and prepared remedial submissions
• Assisted in defending a company before a government investigation of a high-profile subject
• Assisted companies with the diligence and acquisition of medical device manufacturers
• Provided counsel on the development, implementation, and maintenance of compliant manufacturing and quality system processes that were innovative and practical
• Assisted in the preparation for, and defense of, international inspection in follow up to import ban
• Assisted in the successful resolution of an importation issue where FDA was preventing product from entering the United States
• Developed and assisted in the execution of a global recall