Dennis C. Gucciardo

Dennis C. Gucciardo

Counsel
Washington, D.C.

Email dennis.gucciardo@​hoganlovells.com

Phone +1 202 637 3590

Fax +1 202 637 5910

Practice groupRegulatory

From product conception to obsolescence, Dennis Gucciardo provides domestic and global medical device manufacturers practical advice to help ensure they are operating in compliance with the myriad of U.S. Food and Drug Administration (FDA) regulations, requirements, and expectations.

From small startup companies to large multinational corporations, Dennis works with companies to avoid FDA enforcement actions. He travels the world preparing, assisting, and defending companies before FDA inspections.

When FDA action does occur, Dennis works with companies to develop risk-based and right-sized action plans to address FDA concerns. This includes 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 the preparation and execution of global remediation plans to help ensure that all company sites act in accordance with company expectations and FDA requirements.

In addition to FDA enforcement activities, Dennis assists in the defense of a criminal investigation and conducting internal investigations of alleged regulatory violations.

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.

Dennis' pro bono project involves representing D.C. inmates before the U.S. Parole Commission as part of the Washington Lawyers' Committee D.C. Prisoners' Project.

While in law school, he was an executive editor of the Florida Law Review, and was a member of the Journal of Technology Law and Policy. Dennis was also elected into the Order of Coif.

Education and admissions

Education

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

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

B.A., University of Florida, cum laude, 2005

Bar admissions and qualifications

District of Columbia

Florida

Representative experience

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.

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