Dennis C. Gucciardo

Dennis C. Gucciardo

Senior Associate, Washington, D.C.

Email dennis.gucciardo@hoganlovells.com

Phone +1 202 637 3590

Fax +1 202 637 5910

Practice groupRegulatory

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.

Education and admissions

Education

J.D., magna cum laude, Order of the Coif, University of Florida, Levin College of Law, 2009

B.S., summa cum laude, University of Florida, 2005

Bar admissions and qualifications

District of Columbia

Florida

Court admissions

U.S. District Court, Middle District of Florida

U.S. District Court, Southern District of Florida

Latest thinking and events

Sponsorships and Speaking Engagements

Inspections

Sponsorships and Speaking Engagements

Definitions, Global Regulations, and Standards

Sponsorships and Speaking Engagements

Complaint Handling Outputs

Sponsorships and Speaking Engagements

Authority for FDA Inspections and the FDA Inspection Process

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