Dennis C. Gucciardo counsels domestic and global medical device manufacturers to help ensure they operate in compliance with the myriad of US Food and Drug Administration (FDA) regulations, requirements, and expectations. He works with companies ranging from small startups to large multinational corporations throughout the product life cycle, helping bring novel technologies to market while maintaining compliance and avoiding FDA enforcement actions.
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.
Life Sciences Star, FDA: Medical Device, LMG Life Sciences Awards Americas (2023, 2024)
Rising Star, Regulatory, LMG Life Sciences Awards Americas (2022)
Recommended, Industry focus: Healthcare: life sciences, The Legal 500 US (2022)
Ranked, Healthcare: Pharmaceutical/Medical Products Regulatory, District of Columbia, Chambers USA (2024)
Up and Coming, Healthcare: Pharmaceutical/Medical Products Regulatory, District of Columbia, Chambers USA (2021–2023)
Recognized, DC Trailblazer, The National Law Journal (2020)
ISO 13485 Certified Auditor
Executive Editor, Florida Law Review, University of Florida
Member, Journal of Technology Law and Policy