Dennis C. Gucciardo
As a senior associate in the firm's accomplished Medical Devices practice, Dennis Gucciardo understands the pressure medical device companies around the world face when working with the U.S. Food and Drug Administration (FDA) to resolve compliance concerns.
From small start-up companies to large multi-national corporations identified as leaders within the medical device space, Dennis has worked with companies to avoid further enforcement from the FDA. From developing corrective action plans to responding to FDA Form 483 inspectional observations, Untitled Letters, and Warning Letters; assisting companies through FDA-requested certified audit programs; and preparing medical device recall plans, Dennis is able to help companies navigate through the myriad of FDA regulations, requirements, and expectations.
Dennis has traveled the world in preparing, assisting and defending companies before routine and directed FDA inspections. Dennis has also prepared and assisted in the execution of global remediation plans to help ensure that all company sites act in accordance with company expectations and FDA requirements.
Dennis also works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions. He has been involved with 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. While in law school, Dennis was an executive editor of the Florida Law Review, and was a member of the Journal of Technology Law and Policy. Dennis was elected into the Order of Coif.
Areas of Focus
Latest thinking and events
Sponsorships and Speaking Engagements
Medical Device Summit, CAPA, Implementing, Maintaining, and Monitoring an Effective Process
3-4 February 2015