Dennis C. Gucciardo

Dennis co-leads the firm’s MedTech group and helps companies bring medical devices to market by helping them navigate the pre-market process, establish a quality system, and comply with post-market requirements. Dennis counsels on all therapeutic and diagnostic areas, ranging from traditional products (e.g., imaging systems and orthopedics) to cutting-edge technology (e.g., artificial intelligence). Dennis is deeply familiar with FDA’s evolving policies for digital health, including those regarding software as a medical device (SaMD), clinical decision support software, mobile apps, and related technologies. Dennis advises clinical laboratories and in vitro diagnostic manufacturers on FDA’s Laboratory Developed Test (LDT) requirements and the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA) regulation. Dennis is also deeply familiar with FDA’s regulation of radiological products (including non-medical devices) and compliance with product reporting requirements.

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 requests for additional information regarding Medical Device Reports (MDRs), FDA Form 483 inspectional observations, “It has come to our attention” letters, untitled letters, and FDA warning letters; FDA-requested certified audit programs; and providing strategic direction on the development and execution of 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’s DC Prisoners’ Project.

Before joining Morgan Lewis, Dennis was counsel at another global law firm.

• Served as lead counsel in negotiating a complex consent decree on behalf of Philips Respironics and certain of its corporate affiliates with the FDA and the Department of Justice (DOJ)
• Counseled clinical laboratories on navigating FDA’s regulation of laboratory-developed tests (LDT)
• Counseled clinical laboratories on CLIA regulations and state law licensing requirements
• Counseled a technology company on the FDA regulatory pathway and marketing submissions regarding the development of a novel, at-home in vitro diagnostic test system
• In response to the COVID-19 pandemic, assisted companies (traditional medical device manufacturers and new market entrants) with navigating FDA enforcement policies and the Emergency Use Authorization (EUA) process to quickly bring products to market
• 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
• As part of the Food and Drug Law Institute’s program with the Center for Devices and Radiological Health, conducted training session for FDA personnel on requirements associated with the Federal Food Drug and Cosmetic Act and its implementing regulations, including the Quality System Regulation, FDA inspections, and similar topics
• Prepared product reports in accordance with FDA’s radiological regulations for consumer electronic equipment and lasers
• Counseled a manufacturer on the state law medical device distribution license requirements, including California’s requirements
• Assisted a nontraditional medical device company with bringing its first medical device to market
• Assisted in preparing a complex pre-market notification and in 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 pre-market 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 resolution of an importation issue where FDA was preventing products from entering the United States
• Developed and assisted in the execution of a global recall